21 C.F.R. PART 872--DENTAL DEVICES


TITLE 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL DEVICES

PART 872--DENTAL DEVICES

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Subpart A--GENERAL PROVISIONS

�872.1
Scope.
�872.3
Effective dates of requirement for premarket approval.
�872.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--DIAGNOSTIC DEVICES

�872.1500
Gingival fluid measurer.
�872.1720
Pulp tester.
�872.1730
Electrode gel for pulp testers.
�872.1740
Caries detection device.
�872.1745
Laser fluorescence caries detection device.
�872.1800
Extraoral source x-ray system.
�872.1810
Intraoral source x-ray system.
�872.1820
Dental x-ray exposure alignment device.
�872.1830
Cephalometer.
�872.1840
Dental x-ray position indicating device.
�872.1850
Lead-lined position indicator.
�872.1870
Sulfide detection device.
�872.1905
Dental x-ray film holder.
�872.2050
Dental sonography device.
�872.2060
Jaw tracking device.
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Subpart C--[RESERVED]

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Subpart D--PROSTHETIC DEVICES

�872.3050
Amalgam alloy.
�872.3060
Noble metal alloy.
�872.3080
Mercury and alloy dispenser.
�872.3100
Dental amalgamator.
�872.3110
Dental amalgam capsule.
�872.3130
Preformed anchor.
�872.3140
Resin applicator.
�872.3150
Articulator.
�872.3165
Precision attachment.
�872.3200
Resin tooth bonding agent.
�872.3220
Facebow.
�872.3240
Dental bur.
�872.3250
Calcium hydroxide cavity liner.
�872.3260
Cavity varnish.
�872.3275
Dental cement.
�872.3285
Preformed clasp.
�872.3300
Hydrophilic resin coating for dentures.
�872.3310
Coating material for resin fillings.
�872.3330
Preformed crown.
�872.3350
Gold or stainless steel cusp.
�872.3360
Preformed cusp.
�872.3400
Karaya and sodium borate with or without acacia denture adhesive.
�872.3410
Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.
�872.3420
Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive.
�872.3450
Ethylene oxide homopolymer and/or karaya denture adhesive.
�872.3480
Polyacrylamide polymer (modified cationic) denture adhesive.
�872.3490
Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
�872.3500
Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
�872.3520
OTC denture cleanser.
�872.3530
Mechanical denture cleaner.
�872.3540
OTC denture cushion or pad.
�872.3560
OTC denture reliner.
�872.3570
OTC denture repair kit.
�872.3580
Preformed gold denture tooth.
�872.3590
Preformed plastic denture tooth.
�872.3600
Partially fabricated denture kit.
�872.3630
Endosseous dental implant abutment.
�872.3640
Endosseous dental implant.
�872.3645
Subperiosteal implant material.
�872.3660
Impression material.
�872.3661
Optical Impression Systems for CAD/CAM.
�872.3670
Resin impression tray material.
�872.3680
Polytetrafluoroethylene (PTFE) vitreous carbon materials.
�872.3690
Tooth shade resin material.
�872.3700
Dental mercury.
�872.3710
Base metal alloy.
�872.3730
Pantograph.
�872.3740
Retentive and splinting pin.
�872.3750
Bracket adhesive resin and tooth conditioner.
�872.3760
Denture relining, repairing, or rebasing resin.
�872.3765
Pit and fissure sealant and conditioner.
�872.3770
Temporary crown and bridge resin.
�872.3810
Root canal post.
�872.3820
Root canal filling resin.
�872.3830
Endodontic paper point.
�872.3840
Endodontic silver point.
�872.3850
Gutta percha.
�872.3890
Endodontic stabilizing splint.
�872.3900
Posterior artificial tooth with a metal insert.
�872.3910
Backing and facing for an artificial tooth.
�872.3920
Porcelain tooth.
�872.3930
Bone grafting material.
�872.3940
Total temporomandibular joint prosthesis.
�872.3950
Glenoid fossa prosthesis.
�872.3960
Mandibular condyle prosthesis.
�872.3970
Interarticular disc prosthesis (interpositional implant).
�872.3980
Endosseous dental implant accessories.
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Subpart E--SURGICAL DEVICES

�872.4120
Bone cutting instrument and accessories.
�872.4130
Intraoral dental drill.
�872.4200
Dental handpiece and accessories.
�872.4465
Gas-powered jet injector.
�872.4475
Spring-powered jet injector.
�872.4535
Dental diamond instrument.
�872.4565
Dental hand instrument.
�872.4600
Intraoral ligature and wire lock.
�872.4620
Fiber optic dental light.
�872.4630
Dental operating light.
�872.4730
Dental injecting needle.
�872.4760
Bone plate.
�872.4840
Rotary scaler.
�872.4850
Ultrasonic scaler.
�872.4880
Intraosseous fixation screw or wire.
�872.4920
Dental electrosurgical unit and accessories.
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Subpart F--THERAPEUTIC DEVICES

�872.5410
Orthodontic appliance and accessories.
�872.5470
Orthodontic plastic bracket.
�872.5500
Extraoral orthodontic headgear.
�872.5525
Preformed tooth positioner.
�872.5550
Teething ring.
�872.5570
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
�872.5580
Oral rinse to reduce the adhesion of dental plaque.
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Subpart G--MISCELLANEOUS DEVICES

�872.6010
Abrasive device and accessories.
�872.6030
Oral cavity abrasive polishing agent.
�872.6050
Saliva absorber.
�872.6070
Ultraviolet activator for polymerization.
�872.6080
Airbrush.
�872.6100
Anesthetic warmer.
�872.6140
Articulation paper.
�872.6200
Base plate shellac.
�872.6250
Dental chair and accessories.
�872.6290
Prophylaxis cup.
�872.6300
Rubber dam and accessories.
�872.6350
Ultraviolet detector.
�872.6390
Dental floss.
�872.6475
Heat source for bleaching teeth.
�872.6510
Oral irrigation unit.
�872.6570
Impression tube.
�872.6640
Dental operative unit and accessories.
�872.6650
Massaging pick or tip for oral hygiene.
�872.6660
Porcelain powder for clinical use.
�872.6670
Silicate protector.
�872.6710
Boiling water sterilizer.
�872.6730
Endodontic dry heat sterilizer.
�872.6770
Cartridge syringe.
�872.6855
Manual toothbrush.
�872.6865
Powered toothbrush.
�872.6870
Disposable flouride tray.
�872.6880
Preformed impression tray.
�872.6890
Intraoral dental wax.
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