Food and Drug Administration, HHS § 872.4535 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 inter- tal appliances. articular disc prosthesis (interposi- (b) Classification. Class I (general con- tional implant) shall have an approved trols). The device is exempt from the PMA or a declared completed PDP in premarket notification procedures in effect before being placed in commer- subpart E of part 807 of this chapter cial distribution. subject to the limitations in § 872.9. [59 FR 65478, Dec. 20, 1994, as amended at 63 [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 71746, Dec. 30, 1998] FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, 2001] § 872.3980 Endosseous dental implant accessories. § 872.4200 Dental handpiece and acces- sories. (a) Identification. Endosseous dental implant accessories are manually pow- (a) Identification. A dental handpiece ered devices intended to aid in the and accessories is an AC-powered, placement or removal of endosseous water-powered, air-powered, or belt- dental implants and abutments, pre- driven, hand-held device that may in- pare the site for placement of clude a foot controller for regulation of endosseous dental implants or abut- speed and direction of rotation or a ments, aid in the fitting of endosseous contra-angle attachment for difficult dental implants or abutments, aid in to reach areas intended to prepare den- the fabrication of dental prosthetics, tal cavities for restorations, such as and be used as an accessory with fillings, and for cleaning teeth. endosseous dental implants when tis- (b) Classification. Class I. sue contact will last less than 1 hour. [55 FR 48439, Nov. 20, 1990] These devices include drill bits, screw- drivers, countertorque devices, place- § 872.4465 Gas-powered jet injector. ment and removal tools, laboratory (a) Identification. A gas-powered jet pieces used for fabrication of dental injector is a syringe device intended to prosthetics, and trial abutments. administer a local anesthetic. The sy- (b) Classification. Class I (general con- ringe is powered by a cartridge con- trols). The device is exempt from the taining pressurized carbon dioxide premarket notification procedures in which provides the pressure to force subpart E of part 807 of this chapter the anesthetic out of the syringe. subject to the limitations in § 872.9. (b) Classification. Class II. [65 FR 60099, Oct. 10, 2000] § 872.4475 Spring-powered jet injector. (a) Identification. A spring-powered Subpart E—Surgical Devices jet injector is a syringe device intended to administer a local anesthetic. The § 872.4120 Bone cutting instrument syringe is powered by a spring mecha- and accessories. nism which provides the pressure to (a) Identification. A bone cutting in- force the anesthetic out of the syringe. strument and accessories is a metal de- (b) Classification. Class II. vice intended for use in reconstructive oral surgery to drill or cut into the § 872.4535 Dental diamond instrument. upper or lower jaw and may be used to (a) Identification. A dental diamond prepare bone to insert a wire, pin, or instrument is an abrasive device in- screw. The device includes the manual tended to smooth tooth surfaces during bone drill and wire driver, powered the fitting of crowns or bridges. The bone drill, rotary bone cutting hand- device consists of a shaft which is in- piece, and AC-powered bone saw. serted into a handpiece and a head (b) Classification. Class II. which has diamond chips imbedded into 389 VerDate Mar<15>2010 18:43 May 19, 2014 Jkt 232077 PO 00000 Frm 00399 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT ofr150 PsN: PC150 § 872.4565 21 CFR Ch. I (4–1–14 Edition) it. Rotation of the diamond instrument materials that were used in the device provides an abrasive action when it before May 28, 1976, it is exempt from contacts a tooth. the premarket notification procedures (b) Classification. Class I. The device in subpart E of part 807 of this chapter is exempt from the premarket notifica- subject to the limitations in § 872.9. tion procedures in subpart E of part 807 of this chapter. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, [52 FR 30097, Aug. 12, 1987, as amended at 59 2001] FR 63008, Dec. 7, 1994] § 872.4600 Intraoral ligature and wire § 872.4565 Dental hand instrument. lock. (a) Identification. A dental hand in- (a) Identification. An intraoral liga- strument is a hand-held device in- ture and wire lock is a metal device in- tended to perform various tasks in gen- tended to constrict fractured bone seg- eral dentistry and oral surgery proce- ments in the oral cavity. The bone seg- dures. The device includes the opera- ments are stabilized by wrapping the tive burnisher, operative amalgam car- ligature (wire) around the fractured rier, operative dental amalgam carver, bone segments and locking the ends to- surgical bone chisel, operative amal- gether. gam and foil condenser, endodontic cu- (b) Classification. Class II. rette, operative curette, periodontic curette, surgical curette, dental sur- § 872.4620 Fiber optic dental light. gical elevator, operative dental exca- 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 [55 FR 48439, Nov. 20, 1990, as amended at 59 crown scissors, endodontic pulp canal FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, filling material spreader, surgical 2001] osteotome chisel, endodontic broach, dental wax carver, endodontic pulp § 872.4630 Dental operating light. canal file, hand instrument for calculus (a) Identification. A dental operating removal, dental depth gauge instru- light, including the surgical headlight, ment, plastic dental filling instrument, is an AC-powered device intended to il- dental instrument handle, surgical tis- luminate oral structures and operating sue scissors, mouth mirror, ortho- areas. dontic band driver, orthodontic band (b) Classification. Class I (general con- pusher, orthodontic band setter, ortho- trols). The device is exempt from the dontic bracket aligner, orthodontic premarket notification procedures in pliers, orthodontic ligature tucking in- subpart E of part 807 of this chapter strument, forceps, for articulation subject to the limitations in § 872.9. paper, forceps for dental dressing, den- tal matrix band, matrix retainer, den- [52 FR 30097, Aug. 12, 1987, as amended at 61 tal retractor, dental retractor acces- FR 1121, Jan. 16, 1996; 66 FR 38799, July 25, sories, periodontic or endodontic irri- 2001] gating syringe, and restorative or im- pression material syringe. § 872.4730 Dental injecting needle. (b) Classification. Class I (general con- (a) Identification. A dental injecting trols). If the device is made of the same needle is a slender, hollow metal device 390 VerDate Mar<15>2010 18:43 May 19, 2014 Jkt 232077 PO 00000 Frm 00400 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT ofr150 PsN: PC150.