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21 CFR Part 872 - Dental Devices

Dental Devices

Subpart B – Diagnostic Devices

Sec. 872.1500 Gingival fluid measurer
Sec. 872.1720 Pulp tester
Sec. 872.1730 Electrode gel for pulp testers
Sec. 872.1740 Caries detection device
Sec. 8721745 Laser fluorescence caries detection device
Sec. 872.1800 Extraoral source x-ray system
Sec. 872.1810 Intraoral source x-ray system
Sec. 872.1820 Dental x-ray exposure alignment device
Sect 872.1830 Cephalometer
Sec. 872.1840 Dental x-ray position indicating device
Sec. 872.1850 Lead-lined position indicator
Sec. 872.1870 Sulfide detection device
Sec. 872.1905 Dental x-ray film holder
Sec. 872.2050 Dental sonography device
Sec. 872.2060 Jaw tracking device

Subpart C [Reserved]

Subpart D – Prosthetic Devices

Sec. 872.3060 Noble metal alloy
Sec. 872.3070 Dental amalgam, mercury, and amalgam alloy
Sec. 872.3080 Mercury and alloy dispenser
Sec. 872.3100 Dental amalgam
Sec. 872.3110 Dental amalgam capsule
Sec. 872.3130 Preformed anchor
Sec. 872.3140 Resin applicator
Sec. 872.3150 Articulator
Sec. 872.3165 Precision attachment
Sec. 872.3200 Resin tooth bonding agent
Sec. 872.3220 Facebow
Sec. 872.3240 Dental bur
Sec. 872.3250 Calcium hydroxide cavity liner
Sec. 872.3260 Cavity varnish
Sec. 872.3275 Dental cement
Sec. 872.3285 Preformed clasp
Sec. 872.3310 Coating material for resin fillings
Sec. 872.3330 Preformed crown
Sec. 872.3360 Preformed cusp
Sec. 872.3400 Karaya and sodium borate with or without acacia denture adhesive
Sec. 872.3410 Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive
Sec. 872.3420 Carboxymethylcellulose sodium and cationic polyacrylic polymer denture adhesive
Sec. 872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive
Sec. 872.3480 Polyacrylamide polymer (modified cationic) denture adhesive
Sec. 8723490 Carboxymethylcellulose sodium and/or polyvinylmethulether maleic acid calcium-sodium double salt denture adhesive
Sec. 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive
Sec. 872.3520 OTC denture cleanser
Sec. 872.3530 Mechanical denture cleaner
Sec. 872.3540 OTC denture cushion or pad
Sec. 872.3560 OTC denture reliner
Sec. 872.3570 OTC denture repair kit
Sec. 872.3580 Preformed gold denture tooth
Sec. 872.3590 Preformed plastic denture tooth
Sec. 872.3590 Preformed plastic denture tooth
Sec. 872.3600 Partially fabricated denture kit
Sec. 872.3630 Endosseous dental implant abutment
Sec. 872.3640 Endosseous dental implant
Sec. 872.3645 Subperiosteal implant material
Sec. 872.3660 Impression material
Sec. 872.3661 Optical Impression Systems for CAD/CAM
Sec. 872.3670 Resin impression tray material
Sec. 872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials
Sec. 872.3690 Tooth shade resin material
Sec. 872.3710 Base metal alloy
Sec. 872.3730 Pantograph
Sec. 872.3740 Retentive and splinting pin
Sec. 872.3750 Bracket adhesive resin and tooth conditioner
Sec. 872.3760 Denture relining, repairing, or rebasing resin
Sec. 872.3765 Pit and fissure sealant and conditioner
Sec. 872.3770 Temporary crown and bridge resin
Sec. 872.3810 Root canal post
Sec. 872.3820 Root canal filling resin
Sec. 872.3830 Endodontic paper point
Sec. 872.3840 Endodontic silver point
Sec. 872.3850 Gutta percha
Sec. 872.3890 Endodontic stabilizing splint
Sec. 872.3900 Posterior artificial tooth with a metal insert
Sec. 872.3910 Backing and facing for an artificial tooth
Sec. 872.3920 Porcelain tooth
Sec. 872.3930 Bone grafting material
Sec. 872.3940 Total temporomandibular joint prosthesis
Sec. 872.3950 Glenoid fossa prosthesis
Sec. 872.3960 Mandibular condyle prosthesis
Sec. 872.3970 Interarticular disc prosthesis (interpositional implant)
Sec. 872.3980 Endosseous dental implant accessories

Subpart E – Surgical Devices

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

Subpart F – Therapeutic Devices

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

Subpart G – Miscellaneous Devices

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