374 Part 872—Dental Devices

§ 870.5800 21 CFR Ch. I (4–1–15 Edition)

(2) ‘‘The maximum pulse amplitude 872.1820 Dental x-ray exposure alignment should not exceed 200 milliamperes. device. The maximum pulse duration should 872.1830 Cephalometer. 872.1840 Dental x-ray position indicating de- not exceed 50 milliseconds.’’ vice. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 872.1850 Lead-lined position indicator. 17737, May 11, 1987; 65 FR 17144, Mar. 31, 2000] 872.1870 Sulfide detection device. 872.1905 Dental x-ray film holder. § 870.5800 Compressible limb sleeve. 872.2050 Dental sonography device. 872.2060 Jaw tracking device. (a) Identification. A compressible limb sleeve is a device that is used to pre- Subpart C [Reserved] vent pooling of blood in a limb by in- flating periodically a sleeve around the Subpart D—Prosthetic Devices limb. 872.3060 Noble metal alloy. (b) Classification. Class II (perform- 872.3070 Dental amalgam, mercury, and ance standards). amalgam alloy. 872.3080 Mercury and alloy dispenser. § 870.5900 Thermal regulating system. 872.3100 Dental amalgamator. 872.3110 Dental amalgam capsule. (a) Identification. A thermal regu- 872.3130 Preformed anchor. lating system is an external system 872.3140 Resin applicator. consisting of a device that is placed in 872.3150 Articulator. contact with the patient and a tem- 872.3165 Precision attachment. perature controller for the device. The 872.3200 Resin tooth bonding agent. system is used to regulate patient tem- 872.3220 Facebow. 872.3240 Dental bur. perature. 872.3250 Calcium hydroxide cavity liner. (b) Classification. Class II (perform- 872.3260 Cavity varnish. ance standards). 872.3275 Dental cement. 872.3285 Preformed clasp. § 870.5925 Automatic rotating tour- 872.3300 Hydrophilic resin coating for den- niquet. tures. 872.3310 Coating material for resin fillings. (a) Identification. An automatic rotat- 872.3330 Preformed crown. ing tourniquet is a device that prevents 872.3350 Gold or stainless steel cusp. blood flow in one limb at a time, which 872.3360 Preformed cusp. temporarily reduces the total blood 872.3400 Karaya and sodium borate with or volume, thereby reducing the normal without acacia denture adhesive. workload of the heart. 872.3410 Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture (b) Classification. Class II (perform- adhesive. ance standards). 872.3420 Carboxymethylcellulose sodium and cationic polyacrylamide polymer PART 872—DENTAL DEVICES denture adhesive. 872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive. Subpart A—General Provisions 872.3480 Polyacrylamide polymer (modified cationic) denture adhesive. Sec. 872.3490 Carboxymethylcellulose sodium 872.1 Scope. and/or polyvinylmethylether maleic acid 872.3 Effective dates of requirement for pre- calcium-sodium double salt denture ad- market approval. hesive. 872.9 Limitations of exemptions from sec- 872.3500 Polyvinylmethylether maleic anhy- tion 510(k) of the Federal Food, Drug, dride (PVM-MA), acid copolymer, and and Cosmetic Act (the act). carboxymethylcellulose sodium (NACMC) denture adhesive. Subpart B—Diagnostic Devices 872.3520 OTC denture cleanser. 872.3530 Mechanical denture cleaner. 872.1500 Gingival fluid measurer. 872.3540 OTC denture cushion or pad. 872.1720 Pulp tester. 872.3560 OTC denture reliner. 872.1730 Electrode gel for pulp testers. 872.3570 OTC denture repair kit. 872.1740 Caries detection device. 872.3580 Preformed gold denture tooth. 872.1745 Laser fluorescence caries detection 872.3590 Preformed plastic denture tooth. device. 872.3600 Partially fabricated denture kit. 872.1800 Extraoral source x-ray system. 872.3630 Endosseous dental implant abut- 872.1810 Intraoral source x-ray system. ment.

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872.3640 Endosseous dental implant. 872.5470 Orthodontic plastic bracket. 872.3645 Subperiosteal implant material. 872.5500 Extraoral orthodontic headgear. 872.3660 Impression material. 872.5525 Preformed tooth positioner. 872.3661 Optical Impression Systems for 872.5550 Teething ring. CAD/CAM. 872.5570 Intraoral devices for snoring and 872.3670 Resin impression tray material. intraoral devices for snoring and obstruc- 872.3680 Polytetrafluoroethylene (PTFE) tive sleep apnea. vitreous carbon materials. 872.5580 Oral rinse to reduce the adhesion of 872.3690 Tooth shade resin material. dental plaque. 872.3710 Base metal alloy. 872.3730 Pantograph. Subpart G—Miscellaneous Devices 872.3740 Retentive and splinting pin. 872.3750 Bracket adhesive resin and tooth 872.6010 Abrasive device and accessories. conditioner. 872.6030 Oral cavity abrasive polishing 872.3760 Denture relining, repairing, or re- agent. basing resin. 872.6050 Saliva absorber. 872.3765 Pit and fissure sealant and condi- 872.6070 Ultraviolet activator for polym- tioner. erization. 872.3770 Temporary crown and bridge resin. 872.6080 Airbrush. 872.3810 Root canal post. 872.6100 Anesthetic warmer. 872.6140 Articulation paper. 872.3820 Root canal filling resin. 872.6200 Base plate shellac. 872.3830 Endodontic paper point. 872.6250 Dental chair and accessories. 872.3840 Endodontic silver point. 872.6290 Prophylaxis cup. 872.3850 Gutta percha. 872.6300 Rubber dam and accessories. 872.3890 Endodontic stabilizing splint. 872.6350 Ultraviolet detector. 872.3900 Posterior artificial tooth with a 872.6390 Dental floss. metal insert. 872.6475 Heat source for bleaching teeth. 872.3910 Backing and facing for an artificial 872.6510 Oral irrigation unit. tooth. 872.6570 Impression tube. 872.3920 Porcelain tooth. 872.6640 Dental operative unit and acces- 872.3930 Bone grafting material. sories. 872.3940 Total temporomandibular joint 872.6650 Massaging pick or tip for oral hy- prosthesis. giene. 872.3950 Glenoid fossa prosthesis. 872.6660 Porcelain powder for clinical use. 872.3960 Mandibular condyle prosthesis. 872.6670 Silicate protector. 872.3970 Interarticular disc prosthesis 872.6710 Boiling water sterilizer. (interpositional implant). 872.6730 Endodontic dry heat sterilizer. 872.3980 Endosseous dental implant acces- 872.6770 Cartridge syringe. sories. 872.6855 Manual toothbrush. 872.6865 Powered toothbrush. Subpart E—Surgical Devices 872.6870 Disposable fluoride tray. 872.6880 Preformed impression tray. 872.4120 Bone cutting instrument and acces- 872.6890 Intraoral dental wax. sories. 872.4130 Intraoral dental drill. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 872.4200 Dental handpiece and accessories. 360j, 371. 872.4465 Gas-powered jet injector. SOURCE: 52 FR 30097, Aug. 12, 1987, unless 872.4475 Spring-powered jet injector. otherwise noted. 872.4535 Dental diamond instrument. 872.4565 Dental hand instrument. EDITORIAL NOTE: Nomenclature changes to 872.4600 Intraoral ligature and wire lock. part 872 appear at 73 FR 35341, June 23, 2008. 872.4620 Fiber optic dental light. 872.4630 Dental operating light. Subpart A—General Provisions 872.4730 Dental injecting needle. 872.4760 Bone plate. § 872.1 Scope. 872.4770 Temporary mandibular condyle reconstruction plate. (a) This part sets forth the classifica- 872.4840 Rotary scaler. tion of dental devices intended for 872.4850 Ultrasonic scaler. human use that are in commercial dis- 872.4880 Intraosseous fixation screw or wire. tribution. 872.4920 Dental electrosurgical unit and ac- (b) The identification of a device in a cessories. regulation in this part is not a precise description of every device that is, or Subpart F—Therapeutic Devices will be, subject to the regulation. A 872.5410 Orthodontic appliance and acces- manufacturer who submits a pre- sories. market notification submission for a

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device under part 807 cannot show tive, whichever is later. See section merely that the device is accurately 501(f)(2)(B) of the act. Accordingly, un- described by the section title and iden- less an effective date of the require- tification provisions of a regulation in ment for premarket approval is shown this part, but shall state why the de- in the regulation for a device classified vice is substantially equivalent to into class III in this part, the device other devices, as required by § 807.87. may be commercially distributed with- (c) To avoid duplicative listings, a out FDA’s issuance of an order approv- dental device that has two or more ing a PMA or declaring completed a types of uses (e.g., used both as a diag- PDP for the device. If FDA promul- nostic device and as a therapeutic de- gates a regulation under section 515(b) vice) is listed in one subpart only. of the act requiring premarket ap- (d) References in this part to regu- proval for a device, section 501(f)(1)(A) latory sections of the Code of Federal of the act applies to the device. Regulations are to chapter I of title 21 (b) Any new, not substantially equiv- unless otherwise noted. alent, device introduced into commer- (e) Guidance documents referenced in cial distribution on or after May 28, this part are available on the Internet 1976, including a device formerly mar- at http://www.fda.gov/MedicalDevices/ keted that has been substantially al- DeviceRegulationandGuidance/ tered, is classified by statute (section GuidanceDocuments/default.htm. 513(f) of the act) into class III without [52 FR 30097, Aug. 12, 1987, as amended at 68 any grace period and FDA must have FR 19737, Apr. 22, 2003; 79 FR 50552, Aug. 25, issued an order approving a PMA or de- 2014] claring completed a PDP for the device before the device is commercially dis- § 872.3 Effective dates of requirement tributed unless it is reclassified. If for premarket approval. FDA knows that a device being com- A device included in this part that is mercially distributed may be a ‘‘new’’ classified into class III (premarket ap- device as defined in this section be- proval) shall not be commercially dis- cause of any new intended use or other tributed after the date shown in the reasons, FDA may codify the statutory regulation classifying the device unless classification of the device into class the manufacturer has an approval III for such new use. Accordingly, the under section 515 of the act (unless an regulation for such a class III device exemption has been granted under sec- states that as of the enactment date of tion 520(g)(2) of the act). An approval the amendments, May 28, 1976, the de- under section 515 of the act consists of vice must have an approval under sec- FDA’s issuance of an order approving tion 515 of the act before commercial an application for premarket approval distribution. (PMA) for the device or declaring com- (c) A device identified in a regulation pleted a product development protocol in this part that is classified into class (PDP) for the device. III and that is subject to the transi- (a) Before FDA requires that a device tional provisions of section 520(1) of the commercially distributed before the act is automatically classified by stat- enactment date of the amendments, or ute into class III and must have an ap- a device that has been found substan- proval under section 515 of the act be- tially equivalent to such a device, has fore being commercially distributed. an approval under section 515 of the Accordingly, the regulation for such a act, FDA must promulgate a regula- class III transitional device states that tion under section 515(b) of the act re- as of the enactment date of the amend- quiring such approval, except as pro- ments, May 28, 1976, the device must vided in paragraphs (b) and (c) of this have an approval under section 515 of section. Such a regulation under sec- the act before commercial distribution. tion 515(b) of the act shall not be effective during the grace period ending on § 872.9 Limitations of exemptions from the 90th day after its promulgation or section 510(k) of the Federal Food, on the last day of the 30th full calendar Drug, and Cosmetic Act (the act). month after the regulation that classi- The exemption from the requirement fies the device into class III is effec- of premarket notification (section

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510(k) of the act) for a generic type of (4) For assessing the risk of cardio- class I or II device is only to the extent vascular diseases; that the device has existing or reason- (5) For use in diabetes management; ably foreseeable characteristics of (6) For identifying or inferring the commercially distributed devices with- identity of a microorganism directly in that generic type or, in the case of from clinical material; in vitro diagnostic devices, only to the (7) For detection of antibodies to extent that misdiagnosis as a result of microorganisms other than using the device would not be associ- immunoglobulin G (IgG) or IgG assays ated with high morbidity or mortality. when the results are not qualitative, or Accordingly, manufacturers of any are used to determine immunity, or the commercially distributed class I or II assay is intended for use in matrices device for which FDA has granted an other than serum or plasma; exemption from the requirement of (8) For noninvasive testing as defined premarket notification must still sub- in § 812.3(k) of this chapter; and mit a premarket notification to FDA before introducing or delivering for in- (9) For near patient testing (point of troduction into interstate commerce care). for commercial distribution the device [65 FR 2314, Jan. 14, 2000] when: (a) The device is intended for a use Subpart B—Diagnostic Devices different from the intended use of a legally marketed device in that generic § 872.1500 Gingival fluid measurer. type of device; e.g., the device is intended for a different medical purpose, (a) Identification. A gingival fluid or the device is intended for lay use measurer is a gauge device intended to where the former intended use was by measure the amount of fluid in the gin- health care professionals only; gival sulcus (depression between the (b) The modified device operates tooth and gums) to determine if there using a different fundamental sci- is a gingivitis condition. entific technology than a legally mar- (b) Classification. Class I (general con- keted device in that generic type of de- trols). The device is exempt from the vice; e.g., a surgical instrument cuts premarket notification procedures in tissue with a laser beam rather than subpart E of part 807 of this chapter with a sharpened metal blade, or an in subject to the limitations in § 872.9. vitro diagnostic device detects or iden- [52 FR 30097, Aug. 12, 1987, as amended at 59 tifies infectious agents by using FR 63007, Dec. 7, 1994; 66 FR 38797, July 25, deoxyribonucleic acid (DNA) probe or 2001] nucleic acid hybridization technology rather than culture or immunoassay § 872.1720 Pulp tester. technology; or (a) Identification. A pulp tester is an (c) The device is an in vitro device AC or battery powered device intended that is intended: to evaluate the pulpal vitality of teeth (1) For use in the diagnosis, moni- by employing high frequency current toring, or screening of neoplastic diseases with the exception of transmitted by an electrode to stimu- immunohistochemical devices; late the nerve tissue in the dental pulp. (2) For use in screening or diagnosis (b) Classification. Class II. of familial or acquired genetic disorders, including inborn errors of me- § 872.1730 Electrode gel for pulp testers. tabolism; (3) For measuring an analyte that (a) Identification. An electrode gel for serves as a surrogate marker for pulp testers is a device intended to be screening, diagnosis, or monitoring applied to the surface of a tooth before life-threatening diseases such as ac- use of a pulp tester to aid conduction quired immune deficiency syndrome of electrical current. (AIDS), chronic or active hepatitis, tu- (b) Classification. Class I (general con- berculosis, or myocardial infarction or trols). The device is exempt from the to monitor therapy; premarket notification procedures in

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subpart E of part 807 of this chapter source (a tube) is located outside the subject to the limitations in § 872.9. mouth. This generic type of device may include patient and equipment sup- [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, ports and component parts. 2001] (b) Classification. Class II.

§ 872.1740 Caries detection device. § 872.1810 Intraoral source x-ray sys- (a) Identification. The caries detection tem. device is a device intended to show the (a) Identification. An intraoral source existence of decay in a patient’s tooth x-ray system is an electrically powered by use of electrical current. device that produces x-rays and is in- (b) Classification. Class II. tended for dental radiographic examination and diagnosis of diseases of the § 872.1745 Laser fluorescence caries teeth, jaw, and oral structures. The x- detection device. ray source (a tube) is located inside the (a) Identification. A laser fluorescence mouth. This generic type of device may caries detection device is a laser, a flu- include patient and equipment sup- orescence detector housed in a dental ports and component parts. handpiece, and a control console that (b) Classification. Class II. performs device calibration, as well as variable tone emitting and fluores- § 872.1820 Dental x-ray exposure align- cence measurement functions. The in- ment device. tended use of the device is to aid in the (a) Identification. A dental x-ray expo- detection of tooth decay by measuring sure alignment device is a device in- increased laser induced fluorescence. tended to position x-ray film and to (b) Classification. Class II, subject to align the examination site with the x- the following special controls: ray beam. (1) Sale, distribution, and use of this (b) Classification. Class I (general con- device are restricted to prescription trols). The device is exempt from the use in accordance with § 801.109 of this premarket notification procedures in chapter; subpart E of part 807 of this chapter (2) Premarket notifications must in- subject to the limitations in § 872.9. clude clinical studies, or other relevant information, that demonstrates that [52 FR 30097, Aug. 12, 1987, as amended at 59 the device aids in the detection of FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, tooth decay by measuring increased 2001] laser induced fluorescence; and (3) The labeling must include de- § 872.1830 Cephalometer. tailed use instructions with pre- (a) Identification. A cephalometer is a cautions that urge users to: device used in dentistry during x-ray (i) Read and understand all directions procedures. The device is intended to before using the device, place and to hold a patient’s head in a (ii) Store probe tips under proper standard position during dental x-rays. conditions, (b) Classification. Class II. (iii) Properly sterilize the emitter-detector handpick before each use, and § 872.1840 Dental x-ray position indi- (iv) Properly maintain and handle cating device. the instrument in the specified manner (a) Identification. A dental x-ray posi- and condition. tion indicating device is a device, such [65 FR 18235, Apr. 7, 2000] as a collimator, cone, or aperture, that is used in dental radiographic examina- § 872.1800 Extraoral source x-ray sys- tion. The device is intended to align tem. the examination site with the x-ray (a) Identification. An extraoral source beam and to restrict the dimensions of x-ray system is an AC-powered device the dental x-ray field by limiting the that produces x-rays and is intended size of the primary x-ray beam. for dental radiographic examination (b) Classification. Class I (general con- and diagnosis of diseases of the teeth, trols). The device is exempt from the jaw, and oral structures. The x-ray premarket notification procedures in

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subpart E of part 807 of this chapter represented as sterile, it is also exempt subject to the limitations in § 872.9. from the current good manufacturing practice requirements of the quality [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, system regulation in part 820 of this 2001] chapter, with the exceptions of § 820.180, with respect to general re- § 872.1850 Lead-lined position indi- quirements concerning records, and cator. § 820.198, with respect to complaint (a) Identification. A lead-lined posi- files. tion indicator is a cone-shaped device [52 FR 30097, Aug. 12, 1987, as amended at 54 lined with lead that is attached to a FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, dental x-ray tube and intended to aid 2001] in positioning the tube, to prevent the misfocusing of the x-rays by absorbing § 872.2050 Dental sonography device. divergent radiation, and to prevent (a) Dental sonography device for moni- leakage of radiation. toring—(1) Identification. A dental (b) Classification. Class I (general controls). The device is exempt from the sonography device for monitoring is an premarket notification procedures in electrically powered device, intended subpart E of part 807 of this chapter to be used to monitor subject to the limitations in § 872.9. temporomandibular joint sounds. The device detects and records sounds made [52 FR 30097, Aug. 12, 1987, as amended at 61 by the temporomandibular joint. FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, (2) Classification. Class I. The device 2001] is exempt from the premarket notifica- § 872.1870 Sulfide detection device. tion provisions of subpart E of part 807 of this chapter subject to § 872.9. (a) Identification. A sulfide detection (b) Dental sonography device for inter- device is a device consisting of an AC- pretation and diagnosis—(1) Identifica- powered control unit, probe handle, tion. A dental sonography device for in- probe tips, cables, and accessories. This device is intended to be used in vivo, to terpretation and diagnosis is an elec- manually measure periodontal pocket trically powered device, intended to in- probing depths, detect the presence or terpret temporomandibular joint absence of bleeding on probing, and de- sounds for the diagnosis of tect the presence of sulfides in peri- temporomandibular joint disorders and odontal pockets, as an adjunct in the associated orofacial pain. The device diagnosis of periodontal diseases in detects, records, displays, and stores adult patients. sounds made by the (b) Classification. Class II (special temporomandibular joint during jaw controls) prescription use in accord- movement. The device interprets these ance with § 801.109 of this chapter; con- sounds to generate meaningful output, formance with recognized standards of either directly or by connection to a biocompatibility, electrical safety, and personal computer. The device may be sterility; clinical and analytical per- part of a system of devices, contrib- formance testing, and proper labeling. uting joint sound information to be considered with data from other diag- [63 FR 59717, Nov. 5, 1998] nostic components. (2) Classification. Class II (special con- § 872.1905 Dental x-ray film holder. trols). The special control for this de- (a) Identification. A dental x-ray film vice is FDA’s guidance document enti- holder is a device intended to position tled ‘‘Class II Special Controls Guid- and to hold x-ray film inside the ance Document: Dental Sonography mouth. and Jaw Tracking Devices.’’ (b) Classification. Class I (general controls). The device is exempt from the [68 FR 67367, Dec. 2, 2003] premarket notification procedures in subpart E of part 807 of this chapter § 872.2060 Jaw tracking device. subject to the limitations in § 872.9. If (a) Jaw tracking device for monitoring the device is not labeled or otherwise mandibular jaw positions relative to the

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maxilla—(1) Identification. A jaw track- in the fabrication of cast or porcelain- ing device for monitoring mandibular fused-to-metal crown and bridge res- jaw positions relative to the maxilla is torations. a nonpowered or electrically powered (b) Classification. Class II (special device that measures and records ana- controls). The special control for these tomical distances and angles in three devices is FDA’s ‘‘Class II Special Con- dimensional space, to determine the trols Guidance Document: Dental relative position of the mandible with Noble Metal Alloys.’’ The devices are respect to the location and position of exempt from the premarket notifica- the maxilla, while at rest and during tion procedures in subpart E of part 807 jaw movement. of this chapter subject to the limita- (2) Classification. Class I (general con- tions in § 872.9. See § 872.1(e) for avail- trols). The device is exempt from the ability of guidance information. premarket notification provisions of subpart E of part 807 of this chapter [69 FR 51766, Aug. 23, 2004] subject to § 872.9. § 872.3070 Dental amalgam, mercury, (b) Jaw tracking device for interpreta- and amalgam alloy. tion of mandibular jaw positions for the diagnosis—(1) Identification. A jaw (a) Identification. Dental amalgam is tracking device for interpretation of a device that consists of a combination mandibular jaw positions relative to of elemental mercury, supplied as a liq- the maxilla for the diagnosis of uid in bulk, sachet, or predosed capsule temporomandibular joint disorders and form, and amalgam alloy composed pri- associated orofacial pain is a nonpow- marily of silver, tin, and copper, sup- ered or electrically powered device plied as a powder in bulk, tablet, or that measures and records anatomical predosed capsule form, for the direct distances and angles to determine the filling of carious lesions or structural relative position of the mandible in defects in teeth. This device also in- three dimensional space, with respect cludes the individual component de- to the location and position of the vices, mercury and amalgam alloy, maxilla, while at rest and during jaw when intended to be combined with movement. The device records, dis- each other to form dental amalgam. plays, and stores information about (b) Classification. Class II (special jaw position. The device interprets jaw controls). The special control for this position to generate meaningful out- device is FDA’s ‘‘Class II Special Con- put, either directly or by connection to trols Guidance Document: Dental a personal computer. The device may Amalgam, Mercury, and Amalgam be a part of a system of devices, con- Alloy.’’ See § 872.1(e) for the availability tributing jaw position information to of this guidance document. be considered with data from other di- [74 FR 38714, Aug. 4, 2009] agnostic components. (2) Classification. Class II (special con- § 872.3080 Mercury and alloy dis- trols). The special control for this de- penser. vice is FDA’s guidance document entitled ‘‘Class II Special Controls Guid- (a) Identification. A mercury and ance Document: Dental Sonography alloy dispenser is a device with a and Jaw Tracking Devices.’’ spring-activated valve intended to measure and dispense into a mixing [68 FR 67367, Dec. 2, 2003] capsule a predetermined amount of dental mercury in droplet form and a Subpart C [Reserved] premeasured amount of alloy pellets. (b) Classification. Class I (general con- Subpart D—Prosthetic Devices trols). The device is exempt from the premarket notification procedures in § 872.3060 Noble metal alloy. subpart E of part 807 of this chapter (a) Identification. A noble metal alloy subject to the limitations in § 872.9. is a device composed primarily of noble [52 FR 30097, Aug. 12, 1987, as amended at 54 metals, such as gold, palladium, plat- FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, inum, or silver, that is intended for use 2001]

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§ 872.3100 Dental amalgamator. premarket notification procedures in (a) Identification. A dental amalga- subpart E of part 807 of this chapter mator is a device, usually AC-powered, subject to the limitations in § 872.9. If intended to mix, by shaking, amalgam the device is not labeled or otherwise capsules containing mercury and den- represented as sterile, the device is ex- tal alloy particles, such as silver, tin, empt from the current good manufac- zinc, and copper. The mixed dental turing practice requirements of the amalgam material is intended for fill- quality system regulation in part 820 of ing dental caries. this chapter, with the exceptions of (b) Classification. Class I (general con- § 820.180, with respect to general re- trols). The device is exempt from the quirements concerning records, and premarket notification procedures in § 820.198, with respect to complaint subpart E of part 807 of this chapter files. subject to the limitations in § 872.9. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, [55 FR 48439, Nov. 20, 1990, as amended at 59 2001] FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001] § 872.3150 Articulator. § 872.3110 Dental amalgam capsule. (a) Identification. An articulator is a (a) Identification. A dental amalgam mechanical device intended to simu- late movements of a patient’s upper capsule is a container device in which and lower jaws. Plaster casts of the pa- silver alloy is intended to be mixed tient’s teeth and gums are placed in with mercury to form dental amalgam. the device to reproduce the occlusion (b) Classification. Class I (general con- (bite) and articulation of the patient’s trols). The device is exempt from the jaws. An articulator is intended to fit premarket notification procedures in dentures or provide orthodontic treat- subpart E of part 807 of this chapter ment. subject to the limitations in § 872.9. (b) Classification. Class I (general con- [52 FR 30097, Aug. 12, 1987, as amended at 54 trols). The device is exempt from the FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, premarket notification procedures in 2001] subpart E of part 807 of this chapter subject to the limitations in § 872.9. If § 872.3130 Preformed anchor. the device is not labeled or otherwise (a) Identification. A preformed anchor represented as sterile, the device is ex- is a device made of austenitic alloys or empt from the current good manufac- alloys containing 75 percent or greater turing practice requirements of the gold or metals of the platinum group quality system regulation in part 820 of intended to be incorporated into a den- this chapter, with the exceptions of tal appliance, such as a denture, to § 820.180, with respect to general re- help stabilize the appliance in the pa- quirements concerning records, and tient’s mouth. § 820.198, with respect to complaint (b) Classification. Class I (general con- files. trols). The device is exempt from the [52 FR 30097, Aug. 12, 1987, as amended at 54 premarket notification procedures in FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, subpart E of part 807 of this chapter 2001] subject to the limitations in § 872.9. [52 FR 30097, Aug. 12, 1987, as amended at 59 § 872.3165 Precision attachment. FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, (a) Identification. A precision attach- 2001] ment or preformed bar is a device made of austenitic alloys or alloys con- § 872.3140 Resin applicator. taining 75 percent or greater gold and (a) Identification. A resin applicator is metals of the platinum group intended a brushlike device intended for use in for use in prosthetic dentistry in con- spreading dental resin on a tooth dur- junction with removable partial den- ing application of tooth shade mate- tures. Various forms of the device are rial. intended to connect a lower partial (b) Classification. Class I (general con- denture with another lower partial trols). The device is exempt from the denture, to connect an upper partial

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denture with another upper partial cut hard metals, plastics, porcelains, denture, to connect either an upper or and similar materials intended for use lower partial denture to a tooth or a in the fabrication of dental devices. crown, or to connect a fixed bridge to a (b) Classification. Class I (general con- partial denture. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to the limitations in § 872.9. subpart E of part 807 of this chapter [52 FR 30097, Aug. 12, 1987, as amended at 59 subject to the limitations in § 872.9. FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001] § 872.3250 Calcium hydroxide cavity liner. § 872.3200 Resin tooth bonding agent. (a) Identification. A calcium hydrox- (a) Identification. A resin tooth bond- ide cavity liner is a device material in- ing agent is a device material, such as tended to be applied to the interior of methylmethacrylate, intended to be a prepared cavity before insertion of painted on the interior of a prepared restorative material, such as amalgam, to protect the pulp of a tooth. cavity of a tooth to improve retention (b) Classification. Class II. of a restoration, such as a filling. (b) Classification. Class II. § 872.3260 Cavity varnish. § 872.3220 Facebow. (a) Identification. Cavity varnish is a device that consists of a compound in- (a) Identification. A facebow is a de- tended to coat a prepared cavity of a vice intended for use in denture fab- tooth before insertion of restorative rication to determine the spatial rela- materials. The device is intended to tionship between the upper and lower prevent penetration of restorative ma- jaws. This determination is intended terials, such as amalgam, into the for use in placing denture casts accu- dentinal tissue. rately into an articulator (§ 872.3150) (b) Classification. Class II. and thereby aiding correct placement of artificial teeth into a denture base. § 872.3275 Dental cement. (b) Classification. Class I (general con- (a) Zinc oxide-eugenol—(1) Identifica- trols). The device is exempt from the tion. Zinc oxide-eugenol is a device premarket notification procedures in composed of zinc oxide-eugenol in- subpart E of part 807 of this chapter tended to serve as a temporary tooth subject to the limitations in § 872.9. If filling or as a base cement to affix a the device is not labeled or otherwise temporary tooth filling, to affix dental represented as sterile, the device is ex- devices such as crowns or bridges, or to empt from the current good manufac- be applied to a tooth to protect the turing practice requirements of the tooth pulp. quality system regulation in part 820 of (2) Classification. Class I (general con- this chapter, with the exceptions of trols). The device is exempt from the § 820.180, with respect to general re- premarket notification procedures in quirements concerning records, and subpart E of part 807 of this chapter § 820.198, with respect to complaint subject to § 872.9. files. (b) Dental cement other than zinc [52 FR 30097, Aug. 12, 1987, as amended at 54 oxide-eugenol—(1) Identification. Dental FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, cement other than zinc oxide-eugenol 2001] is a device composed of various materials other than zinc oxide-eugenol in- § 872.3240 Dental bur. tended to serve as a temporary tooth (a) Identification. A dental bur is a ro- filling or as a base cement to affix a tary cutting device made from carbon temporary tooth filling, to affix dental steel or tungsten carbide intended to devices such as crowns or bridges, or to cut hard structures in the mouth, such be applied to a tooth to protect the as teeth or bone. It is also intended to tooth pulp.

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(2) Classification. Class II. functional restoration until a permanent crown is constructed. The device [52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2314, Jan. 14, 2000] also may be intended for use as a functional restoration for a badly decayed § 872.3285 Preformed clasp. deciduous (baby) tooth until the adult (a) Identification. A preformed clasp tooth erupts. or a preformed wire clasp is a prefab- (b) Classification. Class I (general con- ricated device made of austenitic al- trols). The device is exempt from the loys or alloys containing 75 percent or premarket notification procedures in greater gold and metals of the plat- subpart E of part 807 of this chapter inum group intended to be incor- subject to the limitations in § 872.9. porated into a dental appliance, such [52 FR 30097, Aug. 12, 1987, as amended at 59 as a partial denture, to help stabilize FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, the appliance in the patient’s mouth by 2001] fastening the appliance to an adjacent tooth. § 872.3350 Gold or stainless steel cusp. (b) Classification. Class I (general controls). The device is exempt from the (a) Identification. A gold or stainless premarket notification procedures in steel cusp is a prefabricated device subpart E of part 807 of this chapter made of austenitic alloys or alloys con- subject to the limitations in § 872.9. taining 75 percent or greater gold and metals of the platinum group or stain- [52 FR 30097, Aug. 12, 1987, as amended at 59 less steel intended to provide a perma- FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] nent cusp (a projection on the chewing surface of a tooth) to achieve occlusal § 872.3300 Hydrophilic resin coating harmony (a proper bite) between the for dentures. teeth and a removable denture. (a) Identification. A hydrophilic resin (b) Classification. Class I (general con- coating for dentures is a device that trols). The device is exempt from the consists of a water-retaining polymer premarket notification procedures in that is intended to be applied to the subpart E of part 807 of this chapter base of a denture before the denture is subject to the limitations in § 872.9. inserted into the patient’s mouth to improve denture retention and com- [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, fort. 2001] (b) Classification. Class II. § 872.3360 Preformed cusp. § 872.3310 Coating material for resin fillings. (a) Identification. A performed cusp is (a) Identification. A coating material a prefabricated device made of plastic for resin fillings is a device intended to or austenitic alloys or alloys con- be applied to the surface of a restora- taining 75 percent or greater gold and tive resin dental filling to attain a metals of the platinum group intended smooth, glaze-like finish on the surface to be used as a temporary cusp (a pro- of the filling. jection on the chewing surface of a (b) Classification. Class II. tooth) to achieve occlusal harmony (a proper bite) before permanent restora- § 872.3330 Preformed crown. tion of a tooth. (a) Identification. A preformed crown (b) Classification. Class I (general con- is a prefabricated device made of plas- trols). The device is exempt from the tic or austenitic alloys or alloys con- premarket notification procedures in taining 75 percent or greater gold and subpart E of part 807 of this chapter metals of the platinum group intended subject to the limitations in § 872.9. to be affixed temporarily to a tooth after removal of, or breakage of, the [52 FR 30097, Aug. 12, 1987, as amended at 59 natural crown (that portion of the FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, tooth that normally protrudes above 2001] the gums). It is intended for use as a

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§ 872.3400 Karaya and sodium borate in a patient’s mouth to improve den- with or without acacia denture ad- ture retention and comfort. hesive. (b) Classification. Class I (general con- (a) Identification. A karaya and so- trols). The device is exempt from the dium borate with or without acacia premarket notification procedures in denture adhesive is a device composed subpart E of part 807 of this chapter of karaya and sodium borate with or subject to the limitations in § 872.9. without acacia intended to be applied [52 FR 30097, Aug. 12, 1987, as amended at 59 to the base of a denture before the den- FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, ture is inserted into patient’s mouth to 2001] improve denture retention and comfort. § 872.3420 Carboxymethylcellulose so- (b) Classification. (1) Class I (general dium and cationic polyacrylamide polymer denture adhesive. controls) if the device contains less than 12 percent by weight of sodium (a) Identification. A borate. The class I device is exempt carboxymethylcellulose sodium and from the premarket notification proce- cationic polyacrylamide polymer den- dures in subpart E of part 807 of this ture adhesive is a device composed of chapter subject to § 872.9. carboxymethylcellulose sodium and (2) Class III if the device contains 12 cationic polyacrylamide polymer in- percent or more by weight of sodium tended to be applied to the base of a borate. denture before the denture is inserted (c) Date PMA or notice of completion of in a patient’s mouth to improve den- a PDP is required. A PMA or a notice of ture retention and comfort. completion of a PDP is required to be (b) Classification. Class III. filed with the Food and Drug Adminis- (c) Date PMA or notice of completion of tration on or before December 26, 1996 a PDP is required. A PMA or a notice of for any karaya and sodium borate with completion of a PDP is required to be or without acacia denture adhesive filed with the Food and Drug Adminis- that was in commercial distribution tration on or before December 26, 1996 before May 28, 1976, or that has, on or for any carboxymethylcellulose sodium before December 26, 1996 been found to and cationic polyacrylamide polymer be substantially equivalent to a karaya denture adhesive that was in commer- and sodium borate with or without aca- cial distribution before May 28, 1976, or cia denture adhesive that was in com- that has, on or before December 26, 1996 mercial distribution before May 28, been found to be substantially equiva- 1976. Any other karaya and sodium bo- lent to a carboxymethylcellulose so- rate with or without acacia denture ad- dium and cationic polyacrylamide hesive shall have an approved PMA or polymer denture adhesive that was in a declared completed PDP in effect be- commercial distribution before May 28, fore being placed in commercial dis- 1976. Any other carboxymethylcellulose tribution. sodium and cationic polyacrylamide polymer denture adhesive shall have an [52 FR 30097, Aug. 12, 1987, as amended at 61 approved PMA or a declared completed FR 50706, Sept. 27, 1996; 65 FR 2315, Jan. 14, PDP in effect before being placed in 2000] commercial distribution. § 872.3410 Ethylene oxide [52 FR 30097, Aug. 12, 1987, as amended at 61 homopolymer and/or FR 50707, Sept. 27, 1996] carboxymethylcellulose sodium denture adhesive. § 872.3450 Ethylene oxide (a) Identification. An ethylene oxide homopolymer and/or karaya den- homopolymer and/or ture adhesive. carboxymethylcellulose sodium den- (a) Identification. Ethylene oxide ture adhesive is a device containing homopolymer and/or karaya denture ethylene oxide homopolymer and/or adhesive is a device composed of ethyl- carboxymethylcellulose sodium in- ene oxide homopolymer and/or karaya tended to be applied to the base of a intended to be applied to the base of a denture before the denture is inserted denture before the denture is inserted

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in a patient’s mouth to improve den- cium-sodium double salt denture adhe- ture retention and comfort. sive is a device composed of (b) Classification. (1) Class I if the de- carboxymethylcellulose sodium and/or vice is made of wax-impregnated cot- polyvinylmethylether maleic acid cal- ton cloth that the patient applies to cium-sodium double salt intended to be the base or inner surface of a denture applied to the base of a denture before before inserting the denture into the the denture is inserted in a patient’s mouth. The device is intended to be mouth to improve denture retention discarded following 1 day’s use. The and comfort. class I device is exempt from the pre- (b) Classification. Class I (general con- market notification procedures in sub- trols). The device is exempt from the part E of part 807 of this chapter sub- premarket notification procedures in ject to § 872.9. subpart E of part 807 of this chapter [52 FR 30097, Aug. 12, 1987, as amended at 59 subject to the limitations in § 872.9. FR 63008, Dec. 7, 1994; 65 FR 2315, Jan. 14, 2000] [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, § 872.3480 Polyacrylamide polymer 2001] (modified cationic) denture adhesive. § 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid co- (a) Identification. A polyacrylamide polymer, and polymer (modified cationic) denture carboxymethylcellulose sodium adhesive is a device composed of (NACMC) denture adhesive. polyacrylamide polymer (modified cat- (a) Identification. ionic) intended to be applied to the Polyvinylmethylether maleic anhy- base of a denture before the denture is dride (PVM-MA), acid copolymer, and inserted in a patient’s mouth to im- carboxymethylcellulose sodium prove denture retention and comfort. (NACMC) denture adhesive is a device (b) Classification. Class III. (c) Date PMA or notice of completion of composed of polyvinylmethylether ma- a PDP is required. A PMA or a notice of leic anhydride, acid copolymer, and completion of a PDP is required to be carboxymethylcellulose sodium in- filed with the Food and Drug Adminis- tended to be applied to the base of a tration on or before December 26, 1996 denture before the denture is inserted for any polyacrylamide polymer (modi- in a patient’s mouth to improve den- fied cationic) denture adhesive that ture retention and comfort. was in commercial distribution before (b) Classification. Class III. May 28, 1976, or that has, on or before (c) Date PMA or notice of completion of December 26, 1996 been found to be sub- a PDP is required. A PMA or a notice of stantially equivalent to a completion of a PDP is required to be polyacrylamide polymer (modified cat- filed with the Food and Drug Adminis- ionic) denture adhesive that was in tration on or before December 26, 1996 commercial distribution before May 28, for any polyvinylmethylether maleic 1976. Any other polyacrylamide poly- anhydride (PVM-MA), acid copolymer, mer (modified cationic) denture adhe- and carboxymethylcellulose sodium sive shall have an approved PMA or a (NACMC) denture adhesive that was in declared completed PDP in effect be- commercial distribution before May 28, fore being place in commercial dis- 1976, or that has, on or before Decem- tribution. ber 26, 1996 been found to be substantially equivalent to a [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996] polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and § 872.3490 Carboxymethylcellulose so- carboxymethylcellulose sodium dium and/or polyvinylmethylether (NACMC) denture adhesive that was in maleic acid calcium-sodium double commercial distribution before May 28, salt denture adhesive. 1976. Any other polyvinylmethylether (a) Identification. A maleic anhydride (PVM-MA), acid co- carboxymethylcellulose sodium and/or polymer, and carboxymethylcellulose polyvinylmethylether maleic acid cal- sodium (NACMC) denture adhesive

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shall have an approved PMA or a de- mouth. The device is intended to be clared completed PDP in effect before discarded following 1 day’s use. The being placed in commercial distribu- class I device is exempt from the pre- tion. market notification procedures in subpart E of part 807 of this chapter sub- [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996] ject to § 872.9. (2) Class II if the OTC denture cush- § 872.3520 OTC denture cleanser. ion or pad is made of a material other than wax-impregnated cotton cloth or (a) Identification. An OTC denture if the intended use of the device differs cleanser is a device that consists of from that described in paragraph (b)(1) material in the form of a powder, tab- of this section. The special controls for let, or paste that is intended to remove this device are FDA’s: debris from removable prosthetic den- (i) ‘‘Use of International Standard tal appliances, such as bridges or den- ISO 10993 ‘Biological Evaluation of tures. The dental appliance is removed Medical—Devices Part I: Evaluation from the patient’s mouth when the ap- and Testing,’ ’’ and pliance is cleaned. (ii) ‘‘OTC Denture Reliners, Repair (b) Classification. Class I (general con- Kits, and Partially Fabricated Denture trols). The device is exempt from the Kits.’’ premarket notification procedures in subpart E of part 807 of this chapter [52 FR 30097, Aug. 12, 1987, as amended at 65 subject to the limitations in § 872.9. FR 2315, 2000; 65 FR 17144, Mar. 31, 2000] [52 FR 30097, Aug. 12, 1987, as amended at 59 § 872.3560 OTC denture reliner. FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, (a) Identification. An OTC denture 2001] reliner is a device consisting of a mate- § 872.3530 Mechanical denture cleaner. rial such as plastic resin that is intended to be applied as a permanent (a) Identification. A mechanical den- coating or lining on the base or tissue- ture cleaner is a device, usually AC- contacting surface of a denture. The powered, that consists of a container device is intended to replace a worn for mechanically agitating a denture denture lining and may be available for cleansing solution. The device is in- purchase over the counter. tended to clean a denture by submer- (b) Classification. Class II. The special sion in the agitating cleansing solution controls for this device are FDA’s: in the container. (1) ‘‘Use of International Standard (b) Classification. Class I (general con- ISO 10993 ‘Biological Evaluation of trols). The device is exempt from the Medical Devices—Part I: Evaluation premarket notification procedures in and Testing,’ ’’ and subpart E of part 807 of this chapter (2) ‘‘OTC Denture Reliners, Repair subject to the limitations in § 872.9. Kits, and Partially Fabricated Denture [55 FR 48439, Nov. 20, 1990, as amended at 59 Kits.’’ FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, [52 FR 30097, Aug. 12, 1987, as amended at 61 2001] FR 50707, Sept. 27, 1996; 65 FR 17144, Mar. 31, 2000] § 872.3540 OTC denture cushion or pad. § 872.3570 OTC denture repair kit. (a) Identification. An OTC denture (a) Identification. An OTC denture re- cushion or pad is a prefabricated or pair kit is a device consisting of a ma- noncustom made disposable device that terial, such as a resin monomer system is intended to improve the fit of a loose of powder and liquid glues, that is in- or uncomfortable denture, and may be tended to be applied permanently to a available for purchase over-the- denture to mend cracks or breaks. The counter. device may be available for purchase (b) Classification. (1) Class I if the de- over-the counter. vice is made of wax-impregnated cot- (b) Classification. Class II. The special ton cloth that the patient applies to controls for this device are FDA’s: the base or inner surface of a denture (1) ‘‘Use of International Standard before inserting the denture into the ISO 10993 ‘Biological Evaluation of

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Medical Devices—Part I: Evaluation (2) ‘‘OTC Denture Reliners, Repair and Testing,’ ’’ and Kits, and Partially Fabricated Denture (2) ‘‘OTC Denture Reliners, Repair Kits.’’ Kits, and Partially Fabricated Denture [52 FR 30097, Aug. 12, 1987, as amended at 65 Kits.’’ FR 17144, Mar. 31, 2000] [52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000] § 872.3630 Endosseous dental implant abutment. § 872.3580 Preformed gold denture (a) Identification. An endosseous den- tooth. tal implant abutment is a (a) Identification. A preformed gold premanufactured prosthetic component denture tooth is a device composed of directly connected to the endosseous austenitic alloys or alloys containing dental implant and is intended for use 75 percent or greater gold and metals of as an aid in prosthetic rehabilitation. the platinum group intended for use as (b) Classification. Class II (special a tooth or a portion of a tooth in a controls). The guidance document enti- fixed or removable partial denture. tled ‘‘Class II Special Controls Guid- (b) Classification. Class I (general con- ance Document: Root-Form trols). The device is exempt from the Endosseous Dental Implants and premarket notification procedures in Endosseous Dental Implant Abut- subpart E of part 807 of this chapter ments’’ will serve as the special con- subject to the limitations in § 872.9. trol. (See § 872.1(e) for the availability of this guidance document.) [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, [69 FR 26304, May 12, 2004] 2001] § 872.3640 Endosseous dental implant. § 872.3590 Preformed plastic denture (a) Identification. An endosseous den- tooth. tal implant is a prescription device (a) Identification. A preformed plastic made of a material such as titanium or denture tooth is a prefabricated device, titanium alloy that is intended to be composed of materials such as methyl surgically placed in the bone of the methacrylate, that is intended for use upper or lower jaw arches to provide as a tooth in a denture. support for prosthetic devices, such as (b) Classification. Class II. artificial teeth, in order to restore a patient’s chewing function. § 872.3600 Partially fabricated denture (b) Classification. (1) Class II (special kit. controls). The device is classified as class II if it is a root-form endosseous (a) Identification. A partially fab- dental implant. The root-form ricated denture kit is a device com- endosseous dental implant is charac- posed of connected preformed teeth terized by four geometrically distinct that is intended for use in construction types: Basket, screw, solid cylinder, of a denture. A denture base is con- and hollow cylinder. The guidance doc- structed using the patient’s mouth as a ument entitled ‘‘Class II Special Con- mold, by partially polymerizing the trols Guidance Document: Root-Form resin denture base materials while the Endosseous Dental Implants and materials are in contact with the oral Endosseous Dental Implant Abut- tissues. After the denture base is con- ments’’ will serve as the special constructed, the connected preformed trol. (See § 872.1(e) for the availability teeth are chemically bonded to the of this guidance document.) base. (2) Classification. Class II (special con- (b) Classification. Class II. The special trols). The device is classified as class controls for this device are FDA’s: II if it is a blade-form endosseous den- (1) ‘‘Use of International Standard tal implant. The special controls for ISO 10993 ‘Biological Evaluation of this device are: Medical Devices—Part I: Evaluation (i) The design characteristics of the and Testing,’ ’’ and device must ensure that the geometry

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and material composition are con- (b) Classification. Class II. sistent with the intended use; (ii) Mechanical performance (fatigue) § 872.3660 Impression material. testing under simulated physiological (a) Identification. Impression material conditions to demonstrate maximum is a device composed of materials such load (endurance limit) when the device as alginate or polysulfide intended to is subjected to compressive and shear be placed on a preformed impression loads; tray and used to reproduce the struc- (iii) Corrosion testing under simu- ture of a patient’s teeth and gums. The lated physiological conditions to dem- device is intended to provide models onstrate corrosion potential of each for study and for production of restora- metal or alloy, couple potential for an tive prosthetic devices, such as gold in- assembled dissimilar metal implant lays and dentures. system, and corrosion rate for an as- (b) Classification. Class II (Special sembled dissimilar metal implant sys- Controls). tem; (iv) The device must be demonstrated [52 FR 30097, Aug. 12, 1987, as amended at 68 to be biocompatible; FR 19738, Apr. 22, 2003] (v) Sterility testing must dem- § 872.3661 Optical Impression Systems onstrate the sterility of the device; for CAD/CAM. (vi) Performance testing to evaluate the compatibility of the device in a (a) Identification. An optical impres- magnetic resonance (MR) environment; sion system for computer assisted de- (vii) Labeling must include a clear sign and manufacturing (CAD/CAM) is description of the technological fea- a device used to record the topo- tures, how the device should be used in graphical characteristics of teeth, den- patients, detailed surgical protocol and tal impressions, or stone models by restoration procedures, relevant pre- analog or digital methods for use in the cautions and warnings based on the computer-assisted design and manufac- clinical use of the device, and quali- turing of dental restorative prosthetic fications and training requirements for devices. Such systems may consist of a device users including technicians and camera, scanner, or equivalent type of clinicians; sensor and a computer with software. (viii) Patient labeling must contain a (b) Classification. Class II (Special description of how the device works, Controls). The device is exempt from how the device is placed, how the pa- the premarket notification procedures tient needs to care for the implant, in subpart E of part 807 of the chapter possible adverse events and how to re- subject to the limitations in § 872.9. The port any complications; and special control for these devices is the (ix) Documented clinical experience FDA guidance document entitled must demonstrate safe and effective ‘‘Class II Special Controls Guidance use and capture any adverse events ob- Document: Optical Impression Systems served during clinical use. for Computer Assisted Design and Man- ufacturing (CAD/CAM) of Dental Res- [69 FR 26304, May 12, 2004, as amended at 79 torations; Guidance for Industry and FR 34625, June 18, 2014] FDA.’’ For the availability of this § 872.3645 Subperiosteal implant mate- guidance document, see § 872.1(e). rial. [68 FR 19738, Apr. 22, 2003] (a) Identification. Subperiosteal implant material is a device composed of § 872.3670 Resin impression tray mate- titanium or cobalt chrome molyb- rial. denum intended to construct custom (a) Identification. Resin impression prosthetic devices which are surgically tray material is a device intended for implanted into the lower or upper jaw use in a two-step dental mold fabri- between the periosteum (connective cating process. The device consists of a tissue covering the bone) and sup- resin material, such as methyl meth- porting bony structures. The device is acrylate, and is used to form a custom intended to provide support for pros- impression tray for use in cases in theses, such as dentures. which a preformed impression tray is

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not suitable, such as the fabrication of § 872.3710 Base metal alloy. crowns, bridges, or full dentures. A pre- (a) Identification. A base metal alloy liminary plaster or stone model of the is a device composed primarily of base patient’s teeth and gums is made. The metals, such as nickel, chromium, or resin impression tray material is ap- cobalt, that is intended for use in fab- plied to this preliminary study model rication of cast or porcelain-fused-to- to form a custom tray. This tray is metal crown and bridge restorations. then filled with impression material and inserted into the patient’s mouth (b) Classification. Class II (special to make an impression, from which a controls). The special control for this final, more precise, model of the pa- device is FDA’s ‘‘Class II Special Con- tient’s mouth is cast. trols Guidance Document: Dental Base Metal Alloys.’’ The device is exempt (b) Classification. Class I (general con- from the premarket notification proce- trols). The device is exempt from the dures in subpart E of part 807 of this premarket notification procedures in chapter subject to the limitations in subpart E of part 807 of this chapter § 872.9. See § 872.1(e) for availability of subject to the limitations in § 872.9. If guidance information. the device is not labeled or otherwise represented as sterile, it is exempt [69 FR 51766, Aug. 23, 2004] from the current good manufacturing practice requirements of the quality § 872.3730 Pantograph. system regulation in part 820 of this (a) Identification. A pantograph is a chapter, with the exception of § 820.180, device intended to be attached to a pa- with respect to general requirements tient’s head to duplicate lower jaw concerning records, and § 820.198, with movements to aid in construction of respect to complaint files. restorative and prosthetic dental de- [52 FR 30097, Aug. 12, 1987, as amended at 59 vices. A marking pen is attached to the FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, lower jaw component of the device and, 2001] as the patient’s mouth opens, the pen records on graph paper the angle be- § 872.3680 Polytetrafluoroethylene tween the upper and the lower jaw. (PTFE) vitreous carbon materials. (b) Classification. Class I (general con- (a) Identification. Polytetrafluoro- trols). The device is exempt from the ethylene (PTFE) vitreous carbon mate- premarket notification procedures in rial is a device composed of polytetra- subpart E of part 807 of this chapter fluoroethylene (PTFE) vitreous carbon subject to the limitations in § 872.9. If intended for use in maxillofacial alve- the device is not labeled or otherwise olar ridge augmentation (building up represented as sterile, it is exempt the upper or lower jaw area that con- from the current good manufacturing tains the sockets in which teeth are practice requirements of the quality rooted) or intended to coat metal sur- system regulation in part 820 of this gical implants to be placed in the chapter, with the exception of § 820.180, alveoli (sockets in which the teeth are with respect to general requirements rooted) or the temporomandibular concerning records, and § 820.198, with joints (the joint between the upper and respect to complaint files. lower jaws). [52 FR 30097, Aug. 12, 1987, as amended at 66 (b) Classification. Class II. FR 38798, July 25, 2001] [52 FR 30097, Aug. 12, 1987; 52 FR 34456, Sept. 11, 1987] § 872.3740 Retentive and splinting pin. (a) Identification. A retentive and § 872.3690 Tooth shade resin material. splinting pin is a device made of aus- (a) Identification. Tooth shade resin tenitic alloys or alloys containing 75 material is a device composed of mate- percent or greater gold and metals of rials such as bisphenol-A glycidyl the platinum group intended to be methacrylate (Bis-GMA) intended to placed permanently in a tooth to pro- restore carious lesions or structural de- vide retention and stabilization for a fects in teeth. restoration, such as a crown, or to join (b) Classification. Class II. two or more teeth together.

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(b) Classification. Class I (general con- gold and metals of the platinum group trols). The device is exempt from the intended to be cemented into the root premarket notification procedures in canal of a tooth to stabilize and sup- subpart E of part 807 of this chapter port a restoration. subject to the limitations in § 872.9 (b) Classification. Class I (general con- [52 FR 30097, Aug. 12, 1987, as amended at 60 trols). The device is exempt from the FR 38900, July 28, 1995; 66 FR 38798, July 25, premarket notification procedures in 2001] subpart E of part 807 of this chapter subject to the limitations in § 872.9. § 872.3750 Bracket adhesive resin and tooth conditioner. [52 FR 30097, Aug. 12, 1987, as amended at 60 (a) Identification. A bracket adhesive FR 38900, July 28, 1995; 66 FR 38798, July 25, resin and tooth conditioner is a device 2001] composed of an adhesive compound, such as polymethylmethacrylate, in- § 872.3820 Root canal filling resin. tended to cement an orthodontic (a) Identification. A root canal filling bracket to a tooth surface. resin is a device composed of material, (b) Classification. Class II. such as methylmethacrylate, intended for use during endodontic therapy to § 872.3760 Denture relining, repairing, fill the root canal of a tooth. or rebasing resin. (b) Classification. (1) Class II if chloro- (a) Identification. A denture relining, form is not used as an ingredient in the repairing, or rebasing resin is a device device. composed of materials such as (2) Class III if chloroform is used as methylmethacrylate, intended to re- an ingredient in the device. line a denture surface that contacts tissue, to repair a fractured denture, or (c) Date PMA or notice of completion of to form a new denture base. This device a PDP is required. A PMA or a notice of is not available for over-the-counter completion of a PDP is required to be (OTC) use. filed with the Food and Drug Adminis- (b) Classification. Class II. tration on or before December 26, 1996 for any root canal filling resin de- § 872.3765 Pit and fissure sealant and scribed in paragraph (b)(2) of this sec- conditioner. tion that was in commercial distribu- (a) Identification. A pit and fissure tion before May 28, 1976, or that has, on sealant and conditioner is a device or before December 26, 1996 been found composed of resin, such as to be substantially equivalent to a root polymethylmethacrylate, intended for canal filling resin described in para- use primarily in young children to seal graph (b)(2) of this section that was in pit and fissure depressions (faults in commercial distribution before May 28, the enamel) in the biting surfaces of 1976. Any other root canal filling resin teeth to prevent cavities. shall have an approved PMA or a de- (b) Classification. Class II. clared completed PDP in effect before § 872.3770 Temporary crown and being placed in commercial distribu- bridge resin. tion. (a) Identification. A temporary crown [52 FR 30097, Aug. 12, 1987, as amended at 61 and bridge resin is a device composed FR 50707, Sept. 27, 1996] of a material, such as polymethylmethacrylate, intended to § 872.3830 Endodontic paper point. make a temporary prosthesis, such as a (a) Identification. An endodontic crown or bridge, for use until a perma- paper point is a device made of paper nent restoration is fabricated. intended for use during endodontic (b) Classification. Class II. therapy to dry, or apply medication to, § 872.3810 Root canal post. the root canal of a tooth. (b) Classification. Class I (general con- (a) Identification. A root canal post is trols). The device is exempt from the a device made of austenitic alloys or alloys containing 75 percent or greater premarket notification procedures in

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subpart E of part 807 of this chapter intended to provide both an improve- subject to the limitations in § 872.9. ment in appearance and functional occlusion (bite). [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the premarket notification procedures in § 872.3840 Endodontic silver point. subpart E of part 807 of this chapter subject to the limitations in § 872.9. (a) Identification. An endodontic silver point is a device made of silver in- [52 FR 30097, Aug. 12, 1987, as amended at 59 tended for use during endodontic ther- FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, apy to fill permanently the root canal 2001] of a tooth. § 872.3910 Backing and facing for an (b) Classification. Class I (general con- artificial tooth. trols). The device is exempt from the premarket notification procedures in (a) Identification. A backing and fac- subpart E of part 807 of this chapter ing for an artificial tooth is a device subject to the limitations in § 872.9. intended for use in fabrication of a fixed or removable dental appliance, [52 FR 30097, Aug. 12, 1987, as amended at 54 such as a crown or bridge. The backing, FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, which is made of gold, is attached to 2001] the dental appliance and supports the tooth-colored facing, which is made of § 872.3850 Gutta percha. porcelain or plastic. (a) Identification. Gutta percha is a (b) Classification. Class I (general con- device made from coagulated sap of trols). The device is exempt from the certain tropical trees intended to fill premarket notification procedures in the root canal of a tooth. The gutta subpart E of part 807 of this chapter percha is softened by heat and inserted subject to the limitations in § 872.9. into the root canal, where it hardens as it cools. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the premarket notification procedures in § 872.3920 Porcelain tooth. subpart E of part 807 of this chapter (a) Identification. A porcelain tooth is subject to the limitations in § 872.9. a prefabricated device made of por- [52 FR 30097, Aug. 12, 1987, as amended at 54 celain powder for clinical use FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, (§ 872.6660) intended for use in construc- 2001] tion of fixed or removable prostheses, such as crowns and partial dentures. § 872.3890 Endodontic stabilizing (b) Classification. Class II. splint. (a) Identification. An endodontic sta- § 872.3930 Bone grafting material. bilizing splint is a device made of a ma- (a) Identification. Bone grafting mate- terial, such as titanium, intended to be rial is a material such as inserted through the root canal into hydroxyapatite, tricalcium phosphate, the upper or lower jaw bone to stabilize polylactic and polyglycolic acids, or a tooth. collagen, that is intended to fill, aug- (b) Classification. Class II. ment, or reconstruct periodontal or bony defects of the oral and maxillo- § 872.3900 Posterior artificial tooth facial region. with a metal insert. (b) Classification. (1) Class II (special (a) Identification. A posterior artifi- controls) for bone grafting materials cial tooth with a metal insert is a por- that do not contain a drug that is a celain device with an insert made of therapeutic biologic. The special con- austenitic alloys or alloys containing trol is FDA’s ‘‘Class II Special Controls 75 percent or greater gold and metals of Guidance Document: Dental Bone the platinum group intended to replace Grafting Material Devices.’’ (See a natural tooth. The device is attached § 872.1(e) for the availability of this to surrounding teeth by a bridge and is guidance document.)

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(2) Class III (premarket approval) for (c) Date PMA or notice of completion of bone grafting materials that contain a a PDP is required. A PMA or a notice of drug that is a therapeutic biologic. completion of a PDP is required to be Bone grafting materials that contain a filed with the Food and Drug Adminis- drug that is a therapeutic biologic, tration on or before March 30, 1999, for such as biological response modifiers, any glenoid fossa prosthesis that was require premarket approval. in commercial distribution before May (c) Date premarket approval application 28, 1976, or that has on or before March (PMA) or notice of product development 30, 1999, been found to be substantially protocol (PDP) is required. Devices de- equivalent to a glenoid fossa prosthesis scribed in paragraph (b)(2) of this sec- that was in commercial distribution tion shall have an approved PMA or a before May 28, 1976. Any other glenoid declared completed PDP in effect be- fossa prosthesis shall have an approved fore being placed in commercial dis- PMA or a declared completed PDP in tribution. effect before being placed in commercial distribution. [70 FR 21949, Apr. 28, 2005] [59 FR 65478, Dec. 20, 1994, as amended at 63 § 872.3940 Total temporomandibular FR 71746, Dec. 30, 1998] joint prosthesis. § 872.3960 Mandibular condyle pros- (a) Identification. A total thesis. temporomandibular joint prosthesis is (a) Identification. A mandibular a device that is intended to be im- condyle prosthesis is a device that is planted in the human jaw to replace intended to be implanted in the human the mandibular condyle and augment jaw to replace the mandibular condyle the glenoid fossa to functionally recon- and to articulate within a glenoid struct the temporomandibular joint. fossa. (b) Class III. Classification. (b) Classification. Class III. (c) Date PMA or notice of completion of (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of a PDP is required. A PMA or a notice of completion of a PDP is required to be completion of a PDP is required to be filed with the Food and Drug Adminis- filed with the Food and Drug Adminis- tration on or before March 30, 1999, for tration on or before March 30, 1999, for any total temporomandibular joint any mandibular condyle prosthesis prosthesis that was in commercial dis- that was in commercial distribution tribution before May 28, 1976, or that before May 28, 1976, or that has, on or has, on or before March 30, 1999, been before March 30, 1999, been found to be found to be substantially equivalent to substantially equivalent to a man- a total temporomandibular joint pros- dibular condyle prosthesis that was in thesis that was in commercial distribu- commercial distribution before May 28, tion before May 28, 1976. Any other 1976. Any other mandibular condyle total temporomandibular joint pros- prosthesis shall have an approved PMA thesis shall have an approved PMA or a or a declared completed PDP in effect declared completed PDP in effect be- before being placed in commercial dis- fore being placed in commercial distribution. tribution. [59 FR 65478, Dec. 20, 1994, as amended at 63 [59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998; 78 FR 79310, Dec. 30, FR 71746, Dec. 30, 1998] 2013]

§ 872.3950 Glenoid fossa prosthesis. § 872.3970 Interarticular disc pros- (a) Identification. A glenoid fossa thesis (interpositional implant). prosthesis is a device that is intended (a) Identification. An interarticular to be implanted in the disc prosthesis (interpositional im- temporomandibular joint to augment a plant) is a device that is intended to be glenoid fossa or to provide an articula- an interface between the natural ar- tion surface for the head of a man- ticulating surface of the mandibular dibular condyle. condyle and glenoid fossa. (b) Classification. Class III. (b) Classification. Class III.

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(c) Date PMA or notice of completion of prepare bone to insert a wire, pin, or a PDP is required. A PMA or a notice of screw. The device includes the manual completion of a PDP is required to be bone drill and wire driver, powered filed with the Food and Drug Adminis- bone drill, rotary bone cutting hand- tration on or before March 30, 1999, for piece, and AC-powered bone saw. any interarticular disc prosthesis (b) Classification. Class II. (interpositional implant) that was in commercial distribution before May 28, § 872.4130 Intraoral dental drill. 1976, or that has on or before March 30, (a) Identification. An intraoral dental 1999, been found to be substantially drill is a rotary device intended to be equivalent to an interarticular disc attached to a dental handpiece to drill prosthesis (interpositional implant) holes in teeth to secure cast or that was in commercial distribution preformed pins to retain operative den- before May 28, 1976. Any other interarticular disc prosthesis (interposi- tal appliances. tional implant) shall have an approved (b) Classification. Class I (general con- PMA or a declared completed PDP in trols). The device is exempt from the effect before being placed in commer- premarket notification procedures in cial distribution. subpart E of part 807 of this chapter subject to the limitations in § 872.9. [59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998] [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, § 872.3980 Endosseous dental implant 2001] accessories. (a) Identification. Endosseous dental § 872.4200 Dental handpiece and acces- implant accessories are manually pow- sories. ered devices intended to aid in the (a) Identification. A dental handpiece placement or removal of endosseous and accessories is an AC-powered, dental implants and abutments, pre- water-powered, air-powered, or belt- pare the site for placement of driven, hand-held device that may in- endosseous dental implants or abut- clude a foot controller for regulation of ments, aid in the fitting of endosseous speed and direction of rotation or a dental implants or abutments, aid in contra-angle attachment for difficult the fabrication of dental prosthetics, to reach areas intended to prepare den- and be used as an accessory with tal cavities for restorations, such as endosseous dental implants when tis- fillings, and for cleaning teeth. sue contact will last less than 1 hour. (b) Classification. Class I. These devices include drill bits, screw- drivers, countertorque devices, place- [55 FR 48439, Nov. 20, 1990] ment and removal tools, laboratory pieces used for fabrication of dental § 872.4465 Gas-powered jet injector. prosthetics, and trial abutments. (a) Identification. A gas-powered jet (b) Classification. Class I (general con- injector is a syringe device intended to trols). The device is exempt from the administer a local anesthetic. The sy- premarket notification procedures in ringe is powered by a cartridge con- subpart E of part 807 of this chapter taining pressurized carbon dioxide subject to the limitations in § 872.9. which provides the pressure to force [65 FR 60099, Oct. 10, 2000] the anesthetic out of the syringe. (b) Classification. Class II.

Subpart E—Surgical Devices § 872.4475 Spring-powered jet injector. § 872.4120 Bone cutting instrument (a) Identification. A spring-powered and accessories. jet injector is a syringe device intended (a) Identification. A bone cutting in- to administer a local anesthetic. The strument and accessories is a metal de- syringe is powered by a spring mecha- vice intended for use in reconstructive nism which provides the pressure to oral surgery to drill or cut into the force the anesthetic out of the syringe. upper or lower jaw and may be used to (b) Classification. Class II.

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§ 872.4535 Dental diamond instrument. strument, forceps, for articulation paper, forceps for dental dressing, den- (a) Identification. A dental diamond instrument is an abrasive device in- tal matrix band, matrix retainer, den- tended to smooth tooth surfaces during tal retractor, dental retractor acces- the fitting of crowns or bridges. The sories, periodontic or endodontic irri- device consists of a shaft which is in- gating syringe, and restorative or im- serted into a handpiece and a head pression material syringe. which has diamond chips imbedded into (b) Classification. Class I (general con- it. Rotation of the diamond instrument trols). If the device is made of the same provides an abrasive action when it materials that were used in the device contacts a tooth. before May 28, 1976, it is exempt from (b) Classification. Class I. The device the premarket notification procedures is exempt from the premarket notifica- in subpart E of part 807 of this chapter tion procedures in subpart E of part 807 subject to the limitations in § 872.9. of this chapter. [52 FR 30097, Aug. 12, 1987, as amended at 54 [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, FR 63008, Dec. 7, 1994] 2001]

§ 872.4565 Dental hand instrument. § 872.4600 Intraoral ligature and wire lock. (a) Identification. A dental hand instrument is a hand-held device in- (a) Identification. An intraoral liga- tended to perform various tasks in gen- ture and wire lock is a metal device in- eral dentistry and oral surgery proce- tended to constrict fractured bone seg- dures. The device includes the opera- ments in the oral cavity. The bone seg- tive burnisher, operative amalgam car- ments are stabilized by wrapping the rier, operative dental amalgam carver, ligature (wire) around the fractured surgical bone chisel, operative amal- bone segments and locking the ends to- gam and foil condenser, endodontic cu- gether. rette, operative curette, periodontic (b) Classification. Class II. curette, surgical curette, dental surgical elevator, operative dental exca- § 872.4620 Fiber optic dental light. vator, operative explorer surgical bone (a) Identification. A fiber optic dental file, operative margin finishing file, light is a device that is a light, usually periodontic file, periodontic probe, sur- AC-powered, that consists of glass or gical rongeur forceps, surgical tooth plastic fibers which have special opti- extractor forceps, surgical hemostat, cal properties. The device is usually at- periodontic hoe, operative matrix tached to a dental handpiece and is in- contouring instrument, operative cut- tended to illuminate a patient’s oral ting instrument, operative margin fin- structures. ishing periodontic knife, periodontic (b) Classification. Class I (general con- marker, operative pliers, endodontic trols). The device is exempt from the root canal plugger, endodontic root premarket notification procedures in canal preparer, surgical biopsy punch, subpart E of part 807 of this chapter endodontic pulp canal reamer, crown subject to the limitations in § 872.9. remover, periodontic scaler, collar and crown scissors, endodontic pulp canal [55 FR 48439, Nov. 20, 1990, as amended at 59 filling material spreader, surgical FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, osteotome chisel, endodontic broach, 2001] dental wax carver, endodontic pulp § 872.4630 Dental operating light. canal file, hand instrument for calculus removal, dental depth gauge instru- (a) Identification. A dental operating ment, plastic dental filling instrument, light, including the surgical headlight, dental instrument handle, surgical tis- is an AC-powered device intended to il- sue scissors, mouth mirror, ortho- luminate oral structures and operating dontic band driver, orthodontic band areas. pusher, orthodontic band setter, ortho- (b) Classification. Class I (general con- dontic bracket aligner, orthodontic trols). The device is exempt from the pliers, orthodontic ligature tucking in- premarket notification procedures in

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subpart E of part 807 of this chapter tached to a powered handpiece to re- subject to the limitations in § 872.9. move calculus deposits from teeth during dental cleaning and periodontal [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38799, July 25, (gum) therapy. 2001] (b) Classification. Class II.

§ 872.4730 Dental injecting needle. § 872.4850 Ultrasonic scaler. (a) Identification. A dental injecting (a) Identification. An ultrasonic scaler needle is a slender, hollow metal device is a device intended for use during den- with a sharp point intended to be at- tal cleaning and periodontal (gum) tached to a syringe to inject local anes- therapy to remove calculus deposits thetics and other drugs. from teeth by application of an ultra- (b) Classification. Class I (general con- sonic vibrating scaler tip to the teeth. trols). The device is exempt from the (b) Classification. Class II. premarket notification procedures in § 872.4880 Intraosseous fixation screw subpart E of part 807 of this chapter or wire. subject to the limitations in § 872.9. (a) Identification. An intraosseous fix- [52 FR 30097, Aug. 12, 1987, as amended at 59 ation screw or wire is a metal device FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, intended to be inserted into fractured 2001] jaw bone segments to prevent their § 872.4760 Bone plate. movement. (b) Classification. Class II. (a) Identification. A bone plate is a metal device intended to stabilize frac- § 872.4920 Dental electrosurgical unit tured bone structures in the oral cav- and accessories. ity. The bone segments are attached to (a) Identification. A dental the plate with screws to prevent move- electrosurgical unit and accessories is ment of the segments. an AC-powered device consisting of a (b) Classification. Class II. controlled power source and a set of cutting and coagulating electrodes. § 872.4770 Temporary mandibular condyle reconstruction plate. This device is intended to cut or remove soft tissue or to control bleeding (a) Identification. A temporary man- during surgical procedures in the oral dibular condyle reconstruction plate is cavity. An electrical current passes a device that is intended to stabilize through the tip of the electrode into mandibular bone and provide for tem- the tissue and, depending upon the op- porary reconstruction of the man- erating mode selected, cuts through dibular condyle until permanent recon- soft tissue or coagulates the tissue. struction is completed in patients who (b) Classification. Class II. have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. Subpart F—Therapeutic Devices This device is not intended for treat- § 872.5410 Orthodontic appliance and ment of temporomandibular joint dis- accessories. orders. (a) Identification. An orthodontic ap- (b) Classification. Class II (special pliance and accessories is a device in- controls). The special controls for this tended for use in orthodontic treat- device is FDA’s guideline entitled ment. The device is affixed to a tooth ‘‘Temporary Mandibular Condyle Re- so that pressure can be exerted on the construction Plate Class II Special teeth. This device includes the Controls Guideline.’’ See § 872.1(e) for preformed orthodontic band, ortho- the availability of this guidance docu- dontic band material, orthodontic elas- ment. tic band, orthodontic metal bracket, [78 FR 79310, Dec. 30, 2013] orthodontic wire clamp, preformed orthodontic space maintainer, ortho- § 872.4840 Rotary scaler. dontic expansion screw retainer, ortho- (a) Identification. A rotary scaler is dontic spring, orthodontic tube, and or- an abrasive device intended to be at- thodontic wire.

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(b) Classification. Class I (general con- (b)(1) Classification. Class I if the trols). The device is exempt from the teething ring does not contain a fluid, premarket notification procedures in such as water. The device is exempt subpart E of part 807 of this chapter from the premarket notification proce- subject to the limitations in § 872.9. dures in subpart E of part 807 of this chapter. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, (2) Class II if the teething ring con- 2001] tains a fluid, such as water. [52 FR 30097, Aug. 12, 1987, as amended at 59 § 872.5470 Orthodontic plastic bracket. FR 63009, Dec. 7, 1994] (a) Identification. An orthodontic plastic bracket is a plastic device in- § 872.5570 Intraoral devices for snor- tended to be bonded to a tooth to apply ing and intraoral devices for snor- pressure to a tooth from a flexible or- ing and obstructive sleep apnea. thodontic wire to alter its position. (a) Identification. Intraoral devices for (b) Classification. Class II. snoring and intraoral devices for snoring and obstructive sleep apnea are de- § 872.5500 Extraoral orthodontic head- vices that are worn during sleep to re- gear. duce the incidence of snoring and to (a) Identification. An extraoral ortho- treat obstructive sleep apnea. The de- dontic headgear is a device intended vices are designed to increase the pa- for use with an orthodontic appliance tency of the airway and to decrease air to exert pressure on the teeth from turbulence and airway obstruction. outside the mouth. The headgear has a The classification includes palatal lift- strap intended to wrap around the pa- ing devices, tongue retaining devices, tient’s neck or head and an inner bow and mandibular repositioning devices. portion intended to be fastened to the (b) Classification. Class II (special orthodontic appliance in the patient’s controls). The special control for these mouth. devices is the FDA guidance document (b) Classification. Class II. entitled ‘‘Class II Special Controls Guidance Document: Intraoral Devices § 872.5525 Preformed tooth positioner. for Snoring and/or Obstructive Sleep (a) Identification. A preformed tooth Apnea; Guidance for Industry and positioner is a plastic device that is an FDA.’’ impression of a perfected bite intended to prevent a patient’s teeth from shift- [67 FR 68512, Nov. 12, 2002] ing position or to move teeth to a final § 872.5580 Oral rinse to reduce the ad- position after orthodontic appliances hesion of dental plaque. (braces) have been removed. The patient bites down on the device for sev- (a) Identification. The device is as- eral hours a day to force the teeth into signed the generic name oral rinse to a final position or to maintain the reduce the adhesion of dental plaque teeth in their corrected position. and is identified as a device intended to (b) Classification. Class I (general con- reduce the presence of bacterial plaque trols). The device is exempt from the on teeth and oral mucosal surfaces by premarket notification procedures in physical means. The device type in- subpart E of part 807 of this chapter cludes those devices that act by reduc- subject to the limitations in § 872.9. ing the attachment and inhibiting the growth of bacterial plaque. [52 FR 30097, Aug. 12, 1987, as amended at 59 (b) Classification. Class II (special FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001] controls). The special control is FDA’s guidance document entitled ‘‘Class II § 872.5550 Teething ring. Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of (a) Identification. A teething ring is a Dental Plaque.’’ See § 872.1(e) for the divice intended for use by infants for availability of this guidance document. medical purposes to soothe gums during the teething process. [70 FR 55028, Sept. 20, 2005]

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Subpart G—Miscellaneous § 872.6050 Saliva absorber. Devices (a) Identification. A saliva absorber is a device made of paper or cotton in- § 872.6010 Abrasive device and acces- tended to absorb moisture from the sories. oral cavity during dental procedures. (a) Identification. An abrasive device (b) Classification. Class I (general con- and accessories is a device constructed trols). The device is exempt from the of various abrasives, such as diamond premarket notification procedures in chips, that are glued to shellac-based subpart E of part 807 of this chapter paper. The device is intended to re- subject to the limitations in § 872.9. If move excessive restorative materials, the device is not labeled or otherwise such as gold, and to smooth rough sur- represented as sterile, it is exempt from the current good manufacturing faces from oral restorations, such as practice requirements of the quality crowns. The device is attached to a system regulation in part 820 of this shank that is held by a handpiece. The chapter, with the exception of § 820.180, device includes the abrasive disk, with respect to general requirements guard for an abrasive disk, abrasive concerning records, and § 820.198, with point, polishing agent strip, and respect to complaint files. polishing wheel. (b) Classification. Class I (general con- [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, trols). The device is exempt from the 2001] premarket notification procedures in subpart E of part 807 of this chapter § 872.6070 Ultraviolet activator for po- subject to the limitations in § 872.9. If lymerization. the device is not labeled or otherwise (a) Identification. An ultraviolet acti- represented as sterile, it is exempt vator for polymerization is a device from the current good manufacturing that produces ultraviolet radiation in- practice requirements of the quality tended to polymerize (set) resinous system regulation in part 820 of this dental pit and fissure sealants or re- chapter, with the exception of § 820.180, storative materials by transmission of with respect to general requirements light through a rod. concerning records, and § 820.198, with (b) Classification. Class II. respect to complaint files. § 872.6080 Airbrush. [52 FR 30097, Aug. 12, 1987, as amended at 54 (a) Identification. An airbrush is an FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, AC-powered device intended for use in 2001] conjunction with articulation paper. The device uses air-driven particles to § 872.6030 Oral cavity abrasive polishing agent. roughen the surfaces of dental restorations. Uneven areas of the restorations (a) Identification. An oral cavity abra- are then identified by use of articula- sive polishing agent is a device in paste tion paper. or powder form that contains an abra- (b) Classification. Class II. The special sive material, such as silica pumice, in- control for this device is International tended to remove debris from the Electrotechnical Commission’s IEC teeth. The abrasive polish is applied to 60601–1–AM2 (1995–03), Amendment 2, the teeth by a handpiece attachment ‘‘Medical Electrical Equipment—Part (prophylaxis cup). 1: General Requirements for Safety.’’ (b) Classification. Class I (general con- [52 FR 30097, Aug. 12, 1987; 52 FR 49250, Dec. trols). The device is exempt from the 30, 1987, as amended at 71 FR 17144, Mar. 31, premarket notification procedures in 2006] subpart E of part 807 of this chapter subject to the limitations in § 872.9. § 872.6100 Anesthetic warmer. (a) Identification. An anesthetic [52 FR 30097, Aug. 12, 1987, as amended at 59 warmer is an AC-powered device into FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, which tubes containing anesthetic so- 2001] lution are intended to be placed to

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warm them prior to administration of § 872.6250 Dental chair and acces- the anesthetic. sories. (b) Classification. Class I (general con- (a) Identification. A dental chair and trols). The device is exempt from the accessories is a device, usually AC- premarket notification procedures in powered, in which a patient sits. The subpart E of part 807 of this chapter device is intended to properly position subject to the limitations in § 872.9. a patient to perform dental procedures. [52 FR 30097, Aug. 12, 1987, as amended at 60 A dental operative unit may be at- FR 38900, July 28, 1995; 66 FR 38799, July 25, tached. 2001] (b) Classification. Class I. The dental chair without the operative unit device § 872.6140 Articulation paper. is exempt from the premarket notifica- (a) Identification. Articulation paper tion procedures in subpart E of part 807 is a device composed of paper coated of this chapter. with an ink dye intended to be placed [55 FR 48439, Nov. 20, 1990, as amended at 59 between the patient’s upper and lower FR 63009, Dec. 7, 1994] teeth when the teeth are in the bite position to locate uneven or high areas. § 872.6290 Prophylaxis cup. (b) Classification. Class I (general con- (a) Identification. A prophylaxis cup is trols). The device is exempt from the a device made of rubber intended to be premarket notification procedures in held by a dental handpiece and used to subpart E of part 807 of this chapter apply polishing agents during prophy- subject to the limitations in § 872.9. If laxis (cleaning). The dental handpiece the device is not labeled or otherwise spins the rubber cup holding the represented as sterile, it is exempt polishing agent and the user applies it from the current good manufacturing to the teeth to remove debris. practice requirements of the quality (b) Classification. Class I (general con- system regulation in part 820 of this trols). The device is exempt from the chapter, with the exception of § 820.180, premarket notification procedures in with respect to general requirements subpart E of part 807 of this chapter concerning records, and § 820.198, with subject to the limitations in § 872.9. If respect to complaint files. the device is not labeled or otherwise [52 FR 30097, Aug. 12, 1987, as amended at 59 represented as sterile, it is exempt FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, from the current good manufacturing 2001] practice requirements of the quality system regulation in part 820 of this § 872.6200 Base plate shellac. chapter, with the exception of § 820.180, (a) Identification. Base plant shellac is with respect to general requirements a device composed of shellac intended concerning records, and § 820.198, with to rebuild the occlusal rim of full or respect to complaint files. partial dentures. [52 FR 30097, Aug. 12, 1987, as amended at 54 (b) Classification. Class I (general con- FR 13831, Apr. 5, 1989; 66 FR 38799, July 25, trols). The device is exempt from the 2001] premarket notification procedures in subpart E of part 807 of this chapter § 872.6300 Rubber dam and acces- subject to the limitations in § 872.9. If sories. the device is not labeled or otherwise (a) Identification. A rubber dam and represented as sterile, it is exempt accessories is a device composed of a from the current good manufacturing thin sheet of latex with a hole in the practice requirements of the quality center intended to isolate a tooth from system regulation in part 820 of this fluids in the mouth during dental pro- chapter, with the exception of § 820.180, cedures, such as filling a cavity prepa- with respect to general requirements ration. The device is stretched around concerning records, and § 820.198, with a tooth by inserting a tooth through a respect to complaint files. hole in the center. The device includes [52 FR 30097, Aug. 12, 1987, as amended at 54 the rubber dam, rubber dam clamp, FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, rubber dam frame, and forceps for a 2001] rubber dam clamp. This classification

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does not include devices intended for premarket notification procedures in use in preventing transmission of sexu- subpart E of part 807 of this chapter ally transmitted diseases through oral subject to the limitations in § 872.9. sex; those devices are classified as [55 FR 48439, Nov. 20, 1990, as amended at 59 condoms in § 884.5300 of this chapter. FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the premarket notification procedures in § 872.6510 Oral irrigation unit. subpart E of part 807 of this chapter (a) Identification. An oral irrigation subject to § 872.9. If the device is not la- unit is an AC-powered device intended beled or otherwise represented as ster- to provide a pressurized stream of ile, it is exempt from the current good water to remove food particles from be- manufacturing practice requirements tween the teeth and promote good peri- of the quality system regulation in odontal (gum) condition. part 820 of this chapter, with the excep- (b) Classification. Class I (general con- tion of § 820.180 of this chapter, with re- trols). The device is exempt from the spect to general requirements con- premarket notification procedures in cerning records, and § 820.198 of this subpart E of part 807 of this chapter chapter, with respect to complaint subject to the limitations in § 872.9. files. [55 FR 48439, Nov. 20, 1990, as amended at 59 [65 FR 2315, Jan. 14, 2000] FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 2001] § 872.6350 Ultraviolet detector. (a) Identification. An ultraviolet de- § 872.6570 Impression tube. tector is a device intended to provide a (a) Identification. An impression tube source of ultraviolet light which is is a device consisting of a hollow cop- used to identify otherwise invisible per tube intended to take an impres- material, such as dental plaque, sion of a single tooth. The hollow tube present in or on teeth. is filled with impression material. One (b) Classification. Class II. end of the tube is sealed with a softened material, such as wax, the re- § 872.6390 Dental floss. maining end is slipped over the tooth (a) Identification. Dental floss is a to make the impression. string-like device made of cotton or (b) Classification. Class I (general con- other fibers intended to remove plaque trols). The device is exempt from the and food particles from between the premarket notification procedures in teeth to reduce tooth decay. The fibers subpart E of part 807 of this chapter of the device may be coated with wax subject to the limitations in § 872.9. If for easier use. the device is not labeled or otherwise (b) Classification. Class I (general con- represented as sterile, it is exempt trols). The device is exempt from the from the current good manufacturing premarket notification procedures in practice requirements of the quality subpart E of part 807 of this chapter system regulation in part 820 of this subject to § 872.9. chapter, with the exception of § 820.180, with respect to general requirements [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 65 FR 2315, Jan. 14, concerning records, and § 820.198, with 2000] respect to complaint files. [52 FR 30097, Aug. 12, 1987, as amended at 54 § 872.6475 Heat source for bleaching FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, teeth. 2001] (a) Identification. A heat source for bleaching teeth is an AC-powered de- § 872.6640 Dental operative unit and vice that consists of a light or an elec- accessories. tric heater intended to apply heat to a (a) Identification. A dental operative tooth after it is treated with a bleach- unit and accessories is an AC-powered ing agent. device that is intended to supply power (b) Classification. Class I (general con- to and serve as a base for other dental trols). The device is exempt from the devices, such as a dental handpiece, a

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dental operating light, an air or water § 872.6670 Silicate protector. syringe unit, and oral cavity (a) Identification. A silicate protector evacuator, a suction operative unit, is a device made of silicone intended to and other dental devices and acces- be applied with an absorbent tipped ap- sories. The device may be attached to a plicator to the surface of a new res- dental chair. toration to exclude temporarily fluids (b) Classification. Class I (general con- from its surface. trols). Except for dental operative unit, (b) Classification. Class I (general con- accessories are exempt from premarket trols). The device is exempt from the notification procedures in subpart E of premarket notification procedures in part 807 of this chapter subject to subpart E of part 807 of this chapter § 872.9. subject to the limitations in § 872.9. If the device is not labeled or otherwise [55 FR 48439, Nov. 20, 1990, as amended at 59 represented as sterile, it is exempt FR 63009, Dec. 7, 1994; 65 FR 2315, Jan. 14, from the current good manufacturing 2000] practice requirements of the quality § 872.6650 Massaging pick or tip for system regulation in part 820 of this oral hygiene. chapter, with the exception of § 820.180, with respect to general requirements (a) Identification. A massaging pick or concerning records, and § 820.198, with tip for oral hygiene is a rigid, pointed respect to complaint files. device intended to be used manually to stimulate and massage the gums to [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, promote good periodontal (gum) condi- 2001] tion. (b) Classification. Class I (general con- § 872.6710 Boiling water sterilizer. trols). The device is exempt from the (a) Identification. A boiling water premarket notification procedures in sterilizer is an AC-powered device that subpart E of part 807 of this chapter consists of a container for boiling subject to the limitations in § 872.9. If water. The device is intended to steri- the device is not labeled or otherwise lize dental and surgical instruments by represented as sterile, it is exempt submersion in the boiling water in the from the current good manufacturing container. practice requirements of the quality (b) Classification. Class I (general con- system regulation in part 820 of this trols). chapter, with the exception of § 820.180, [55 FR 48439, Nov. 20, 1990, as amended at 66 with respect to general requirements FR 46952, Sept. 10, 2001] concerning records, and § 820.198, with respect to complaint files. § 872.6730 Endodontic dry heat sterilizer. [52 FR 30097, Aug. 12, 1987, as amended at 54 (a) Identification. An endodontic dry FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, 2001] heat sterilizer is a device intended to sterilize endodontic and other dental § 872.6660 Porcelain powder for clin- instruments by the application of dry ical use. heat. The heat is supplied through glass beads which have been heated by (a) Identification. Porcelain powder electricity. for clinical use is a device consisting of (b) Classification. Class III. a mixture of kaolin, felspar, quartz, or (c) Date premarket approval application other substances intended for use in (PMA) or notice of completion of product the production of artificial teeth in development protocol (PDP) is required. A fixed or removable dentures, of jacket PMA or notice of completion of a PDP crowns, facings, and veneers. The de- is required to be filed with the Food vice is used in prosthetic dentistry by and Drug Administration on or before heating the powder mixture to a high April 21, 1997, for any endodontic dry temperature in an oven to produce a heat sterilizer that was in commercial hard prosthesis with a glass-like finish. distribution before May 28, 1976, or that (b) Classification. Class II. has on or before April 21, 1997, been

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found to be substantially equivalent to chanical movement to a brush intended the endodontic dry heat sterilizer that to be applied to the teeth. The device is was in commercial distribution before intended to remove adherent plaque May 28, 1976. Any other endodontic dry and food debris from the teeth to re- heat sterilizer shall have an approved duce tooth decay. PMA or declared completed PDP in ef- (b) Classification. Class I (general con- fect before being placed in commercial trols). The device is exempt from the distribution. premarket notification procedures in subpart E of part 807 of this chapter [52 FR 30097, Aug. 12, 1987, as amended at 62 subject to the limitations in § 872.9. FR 2902, Jan. 21, 1997; 62 FR 31512, June 10, 1997] [55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, § 872.6770 Cartridge syringe. 2001] (a) Identification. A cartridge syringe § 872.6870 Disposable fluoride tray. is a device intended to inject anesthetic agents subcutaneously or (a) Identification. A disposable fluo- intramuscularly. The device consists of ride tray is a device made of styrofoam a metal syringe body into which a dis- intended to apply fluoride topically to posable, previously filled, glass carpule the teeth. To use the tray, the patient (a cylindrical cartridge) containing an- bites down on the tray which has been esthetic is placed. After attaching a filled with a fluoride solution. needle to the syringe body and acti- (b) Classification. Class I (general con- vating the carpule by partially insert- trols). The device is exempt from the ing the plunger on the syringe, the de- premarket notification procedures in vice is used to administer an injection subpart E of part 807 of this chapter to the patient. subject to the limitations in § 872.9. If (b) Classification. Class II. the device is not labeled or otherwise represented as sterile, it is exempt § 872.6855 Manual toothbrush. from the current good manufacturing practice requirements of the quality (a) Identification. A manual tooth- system regulation in part 820 of this brush is a device composed of a shaft chapter, with the exception of § 820.180, with either natural or synthetic bris- with respect to general requirements tles at one end intended to remove ad- concerning records, and § 820.198, with herent plaque and food debris from the respect to complaint files. teeth to reduce tooth decay. (b) Classification. Class I (general con- [52 FR 30097, Aug. 12, 1987, as amended at 54 trols). The device is exempt from the FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, 2001] premarket notification procedures in subpart E of part 807 of this chapter § 872.6880 Preformed impression tray. subject to the limitations in § 872.9. If (a) A preformed im- the device is not labeled or otherwise Identification. pression tray is a metal or plastic de- represented as sterile, it is exempt vice intended to hold impression mate- from the current good manufacturing rial, such as alginate, to make an im- practice requirements of the quality pression of a patient’s teeth or alveolar system regulation in part 820 of this process (bony tooth sockets) to repro- chapter, with the exception of § 820.180, duce the structure of a patient’s teeth with respect to general requirements and gums. concerning records, and § 820.198, with (b) Classification. Class I (general con- respect to complaint files. trols). The device is exempt from the [52 FR 30097, Aug. 12, 1987, as amended at 54 premarket notification procedures in FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, subpart E of part 807 of this chapter 2001] subject to the limitations in § 872.9. If the device is not labeled or otherwise § 872.6865 Powered toothbrush. represented as sterile, it is exempt (a) Identification. A powered tooth- from the current good manufacturing brush is an AC-powered or battery-pow- practice requirements of the quality ered device that consists of a handle system regulation in part 820 of this containing a motor that provides me- chapter, with the exception of § 820.180,

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with respect to general requirements 874.1600 Olfactory test device. concerning records, and § 820.198, with 874.1800 Air or water caloric stimulator. respect to complaint files. 874.1820 Surgical nerve stimulator/locator. 874.1925 Toynbee diagnostic tube. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38800, July 25, Subpart C [Reserved] 2001] Subpart D—Prosthetic Devices § 872.6890 Intraoral dental wax. 874.3300 Hearing aid. (a) Identification. Intraoral dental 874.3305 Wireless air-conduction hearing aid. wax is a device made of wax intended 874.3310 Hearing aid calibrator and analysis to construct patterns from which cus- system. tom made metal dental prostheses, 874.3320 Group hearing aid or group audi- such as crowns and bridges, are cast. In tory trainer. orthodontic dentistry, the device is in- 874.3330 Master hearing aid. tended to make a pattern of a patient’s 874.3375 Battery-powered artificial larynx. bite to make study models of the teeth. 874.3400 Tinnitus masker. 874.3430 Middle ear mold. (b) Classification. Class I (general con- 874.3450 Partial ossicular replacement pros- trols). The device is exempt from the thesis. premarket notification procedures in 874.3495 Total ossicular replacement pros- subpart E of part 807 of this chapter thesis. subject to the limitations in § 872.9. If 874.3540 Prosthesis modification instrument the device is not labeled or otherwise for ossicular replacement surgery. represented as sterile, it is exempt 874.3620 Ear, nose, and throat synthetic from the current good manufacturing polymer material. practice requirements of the quality 874.3695 Mandibular implant facial prosthesis. system regulation in part 820 of this 874.3730 Laryngeal prosthesis (Taub design). chapter, with the exception of § 820.180, 874.3760 Sacculotomy tack (Cody tack). with respect to general requirements 874.3820 Endolymphatic shunt. concerning records, and § 820.198, with 874.3850 Endolymphatic shunt tube with respect to complaint files. valve. 874.3880 Tympanostomy tube. [52 FR 30097, Aug. 12, 1987, as amended at 59 874.3900 Nasal dilator. FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 874.3930 Tympanostomy tube with 2001] semipermeable membrane. 874.3950 Transcutaneous air conduction PART 874—EAR, NOSE, AND hearing aid system. THROAT DEVICES Subpart E—Surgical Devices Subpart A—General Provisions 874.4100 Epistaxis balloon. 874.4140 Ear, nose, and throat bur. Sec. 874.4175 Nasopharyngeal catheter. 874.1 Scope. 874.4250 Ear, nose, and throat electric or 874.3 Effective dates of requirement for pre- pneumatic surgical drill. market approval. 874.4350 Ear, nose, and throat fiberoptic 874.9 Limitations of exemptions from sec- light source and carrier. tion 510(k) of the Federal Food, Drug, 874.4420 Ear, nose, and throat manual sur- and Cosmetic Act (the act). gical instrument. Subpart B—Diagnostic Devices 874.4490 Argon laser for otology, rhinology, and laryngology. 874.1050 Audiometer. 874.4500 Ear, nose, and throat microsurgical 874.1060 Acoustic chamber for audiometric carbon dioxide laser. testing. 874.4680 Bronchoscope (flexible or rigid) and 874.1070 Short increment sensitivity index accessories. (SISI) adapter. 874.4710 Esophagoscope (flexible or rigid) 874.1080 Audiometer calibration set. and accessories. 874.1090 Auditory impedance tester. 874.4720 Mediastinoscope and accessories. 874.1100 Earphone cushion for audiometric 874.4750 Laryngostroboscope. testing. 874.4760 Nasopharyngoscope (flexible or 874.1120 Electronic noise generator for rigid) and accessories. audiometric testing. 874.4770 Otoscope. 874.1325 Electroglottograph. 874.4780 Intranasal splint. 874.1500 Gustometer. 874.4800 Bone particle collector.

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