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Food and Drug Administration, HHS § 872.4620

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Food and Drug Administration, HHS § 872.4620 Food and Drug Administration, HHS § 872.4620 § 872.4465 Gas-powered jet injector. ishing periodontic knife, periodontic (a) Identification. A gas-powered jet marker, operative pliers, endodontic injector is a syringe device intended to root canal plugger, endodontic root administer a local anesthetic. The sy- canal preparer, surgical biopsy punch, ringe is powered by a cartridge con- endodontic pulp canal reamer, crown taining pressurized carbon dioxide remover, periodontic scaler, collar and which provides the pressure to force crown scissors, endodontic pulp canal the anesthetic out of the syringe. filling material spreader, surgical (b) Classification. Class II. osteotome chisel, endodontic broach, dental wax carver, endodontic pulp § 872.4475 Spring-powered jet injector. canal file, hand instrument for calculus removal, dental depth gauge instru- (a) Identification. A spring-powered ment, plastic dental filling instrument, jet injector is a syringe device intended dental instrument handle, surgical tis- to administer a local anesthetic. The sue scissors, mouth mirror, ortho- syringe is powered by a spring mecha- dontic band driver, orthodontic band nism which provides the pressure to pusher, orthodontic band setter, ortho- force the anesthetic out of the syringe. dontic bracket aligner, orthodontic (b) Classification. Class II. pliers, orthodontic ligature tucking in- § 872.4535 Dental diamond instrument. strument, forceps, for articulation paper, forceps for dental dressing, den- (a) Identification. A dental diamond tal matrix band, matrix retainer, den- instrument is an abrasive device in- tal retractor, dental retractor acces- tended to smooth tooth surfaces during sories, periodontic or endodontic irri- the fitting of crowns or bridges. The gating syringe, and restorative or im- device consists of a shaft which is in- pression material syringe. serted into a handpiece and a head (b) Classification. Class I (general con- which has diamond chips imbedded into trols). If the device is made of the same 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 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 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] § 872.4565 Dental hand instrument. § 872.4600 Intraoral ligature and wire lock. (a) Identification. A dental hand in- strument 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 sur- gical 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. 447 VerDate Sep<11>2014 10:50 Jul 18, 2019 Jkt 247077 PO 00000 Frm 00457 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB.
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