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FEDERAL · 21 CFR

Part 872 — Dental Devices

140 sections · Title 21: Food and Drugs

§ 872.1Scope.
§ 872.3Effective dates of requirement for premarket approval.
§ 872.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 872.1500Gingival fluid measurer.
§ 872.1720Pulp tester.
§ 872.1730Electrode gel for pulp testers.
§ 872.1740Caries detection device.
§ 872.1745Laser fluorescence caries detection device.
§ 872.1800Extraoral source x-ray system.
§ 872.1810Intraoral source x-ray system.
§ 872.1820Dental x-ray exposure alignment device.
§ 872.1830Cephalometer.
§ 872.1840Dental x-ray position indicating device.
§ 872.1850Lead-lined position indicator.
§ 872.1870Sulfide detection device.
§ 872.1905Dental x-ray film holder.
§ 872.2050Dental sonography device.
§ 872.2060Jaw tracking device.
§ 872.3060Noble metal alloy.
§ 872.3070Dental amalgam, mercury, and amalgam alloy.
§ 872.3080Mercury and alloy dispenser.
§ 872.3100Dental amalgamator.
§ 872.3110Dental amalgam capsule.
§ 872.3130Preformed anchor.
§ 872.3140Resin applicator.
§ 872.3150Articulator.
§ 872.3165Precision attachment.
§ 872.3200Resin tooth bonding agent.
§ 872.3220Facebow.
§ 872.3240Dental bur.
§ 872.3250Calcium hydroxide cavity liner.
§ 872.3260Cavity varnish.
§ 872.3275Dental cement.
§ 872.3285Preformed clasp.
§ 872.3300Hydrophilic resin coating for dentures.
§ 872.3310Coating material for resin fillings.
§ 872.3330Preformed crown.
§ 872.3350Gold or stainless steel cusp.
§ 872.3360Preformed cusp.
§ 872.3400Karaya and sodium borate with or without acacia denture adhesive.
§ 872.3410Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.
§ 872.3420Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive.
§ 872.3450Ethylene oxide homopolymer and/or karaya denture adhesive.
§ 872.3480Polyacrylamide polymer (modified cationic) denture adhesive.
§ 872.3490Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
§ 872.3500Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
§ 872.3520OTC denture cleanser.
§ 872.3530Mechanical denture cleaner.
§ 872.3540OTC denture cushion or pad.
§ 872.3560OTC denture reliner.
§ 872.3570OTC denture repair kit.
§ 872.3580Preformed gold denture tooth.
§ 872.3590Preformed plastic denture tooth.
§ 872.3600Partially fabricated denture kit.
§ 872.3630Endosseous dental implant abutment.
§ 872.3640Endosseous dental implant.
§ 872.3645Subperiosteal implant material.
§ 872.3660Impression material.
§ 872.3661Optical Impression Systems for CAD/CAM.
§ 872.3670Resin impression tray material.
§ 872.3680Polytetrafluoroethylene (PTFE) vitreous carbon materials.
§ 872.3690Tooth shade resin material.
§ 872.3710Base metal alloy.
§ 872.3730Pantograph.
§ 872.3740Retentive and splinting pin.
§ 872.3750Bracket adhesive resin and tooth conditioner.
§ 872.3760Denture relining, repairing, or rebasing resin.
§ 872.3765Pit and fissure sealant and conditioner.
§ 872.3770Temporary crown and bridge resin.
§ 872.3810Root canal post.
§ 872.3820Root canal filling resin.
§ 872.3830Endodontic paper point.
§ 872.3840Endodontic silver point.
§ 872.3850Gutta percha.
§ 872.3890Endodontic stabilizing splint.
§ 872.3900Posterior artificial tooth with a metal insert.
§ 872.3910Backing and facing for an artificial tooth.
§ 872.3920Porcelain tooth.
§ 872.3930Bone grafting material.
§ 872.3940Total temporomandibular joint prosthesis.
§ 872.3950Glenoid fossa prosthesis.
§ 872.3960Mandibular condyle prosthesis.
§ 872.3970Interarticular disc prosthesis (interpositional implant).
§ 872.3980Endosseous dental implant accessories.
§ 872.4120Bone cutting instrument and accessories.
§ 872.4130Intraoral dental drill.
§ 872.4200Dental handpiece and accessories.
§ 872.4465Gas-powered jet injector.
§ 872.4475Spring-powered jet injector.
§ 872.4535Dental diamond instrument.
§ 872.4565Dental hand instrument.
§ 872.4600Intraoral ligature and wire lock.
§ 872.4620Fiber optic dental light.
§ 872.4630Dental operating light.
§ 872.4730Dental injecting needle.
§ 872.4760Bone plate.
§ 872.4770Temporary mandibular condyle reconstruction plate.
§ 872.4840Rotary scaler.
§ 872.4850Ultrasonic scaler.
§ 872.4880Intraosseous fixation screw or wire.
§ 872.4920Dental electrosurgical unit and accessories.
§ 872.5410Orthodontic appliance and accessories.
§ 872.5470Orthodontic plastic bracket.
§ 872.5500Extraoral orthodontic headgear.
§ 872.5525Preformed tooth positioner.
§ 872.5550Teething ring.
§ 872.5560Electrical salivary stimulatory system.
§ 872.5570Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
§ 872.5571Auto titration device for oral appliances.
§ 872.5575Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea.
§ 872.5580Oral rinse to reduce the adhesion of dental plaque.
§ 872.6010Abrasive device and accessories.
§ 872.6030Oral cavity abrasive polishing agent.
§ 872.6050Saliva absorber.
§ 872.6070Ultraviolet activator for polymerization.
§ 872.6080Airbrush.
§ 872.6100Anesthetic warmer.
§ 872.6140Articulation paper.
§ 872.6200Base plate shellac.
§ 872.6250Dental chair and accessories.
§ 872.6290Prophylaxis cup.
§ 872.6300Rubber dam and accessories.
§ 872.6350Ultraviolet detector.
§ 872.6390Dental floss.
§ 872.6475Heat source for bleaching teeth.
§ 872.6510Oral irrigation unit.
§ 872.6570Impression tube.
§ 872.6640Dental operative unit and accessories.
§ 872.6650Massaging pick or tip for oral hygiene.
§ 872.6660Porcelain powder for clinical use.
§ 872.6670Silicate protector.
§ 872.6710Boiling water sterilizer.
§ 872.6730Endodontic dry heat sterilizer.
§ 872.6770Cartridge syringe.
§ 872.6855Manual toothbrush.
§ 872.6865Powered toothbrush.
§ 872.6866Radiofrequency toothbrush.
§ 872.6870Disposable fluoride tray.
§ 872.6880Preformed impression tray.
§ 872.6890Intraoral dental wax.