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Electronic Code of Federal Regulations

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e-CFR Data is current as of July 28, 2014

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

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

§872.3060
Noble metal alloy.
§872.3070
Dental amalgam, mercury, and amalgam 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.
§872.3710
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.
§872.4770
Temporary mandibular condyle reconstruction 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 fluoride tray.
§872.6880
Preformed impression tray.
§872.6890
Intraoral dental wax.


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