21 CFR Part 872
PART 872—DENTAL DEVICES
- PART 872—DENTAL DEVICES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- 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).
- 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.
- Subpart C [Reserved]
- 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.
- 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.
- 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.
- § 872.5560 Electrical salivary stimulatory system.
- § 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
- § 872.5571 Auto titration device for oral appliances.
- § 872.5575 Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea.
- § 872.5580 Oral rinse to reduce the adhesion of dental plaque.
- § 872.5590 Intraoral cooling device.
- 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.
- § 872.6866 Radiofrequency toothbrush.
- § 872.6870 Disposable fluoride tray.
- § 872.6880 Preformed impression tray.
- § 872.6890 Intraoral dental wax.
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