Title 21

PART 872

Part 872 - Dental Devices

PART 872 - DENTAL DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:52 FR 30097, Aug. 12, 1987, unless otherwise noted. Editorial Note:Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.23.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.23.1.1.1SECTION 872.1
   872.1 Scope.
21:8.0.1.1.23.1.1.2SECTION 872.3
   872.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.23.1.1.3SECTION 872.9
   872.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.23.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.23.2.1.1SECTION 872.1500
   872.1500 Gingival fluid measurer.
21:8.0.1.1.23.2.1.2SECTION 872.1720
   872.1720 Pulp tester.
21:8.0.1.1.23.2.1.3SECTION 872.1730
   872.1730 Electrode gel for pulp testers.
21:8.0.1.1.23.2.1.4SECTION 872.1740
   872.1740 Caries detection device.
21:8.0.1.1.23.2.1.5SECTION 872.1745
   872.1745 Laser fluorescence caries detection device.
21:8.0.1.1.23.2.1.6SECTION 872.1800
   872.1800 Extraoral source x-ray system.
21:8.0.1.1.23.2.1.7SECTION 872.1810
   872.1810 Intraoral source x-ray system.
21:8.0.1.1.23.2.1.8SECTION 872.1820
   872.1820 Dental x-ray exposure alignment device.
21:8.0.1.1.23.2.1.9SECTION 872.1830
   872.1830 Cephalometer.
21:8.0.1.1.23.2.1.10SECTION 872.1840
   872.1840 Dental x-ray position indicating device.
21:8.0.1.1.23.2.1.11SECTION 872.1850
   872.1850 Lead-lined position indicator.
21:8.0.1.1.23.2.1.12SECTION 872.1870
   872.1870 Sulfide detection device.
21:8.0.1.1.23.2.1.13SECTION 872.1905
   872.1905 Dental x-ray film holder.
21:8.0.1.1.23.2.1.14SECTION 872.2050
   872.2050 Dental sonography device.
21:8.0.1.1.23.2.1.15SECTION 872.2060
   872.2060 Jaw tracking device.
21:8.0.1.1.23.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.23.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.23.4.1.1SECTION 872.3060
   872.3060 Noble metal alloy.
21:8.0.1.1.23.4.1.2SECTION 872.3070
   872.3070 Dental amalgam, mercury, and amalgam alloy.
21:8.0.1.1.23.4.1.3SECTION 872.3080
   872.3080 Mercury and alloy dispenser.
21:8.0.1.1.23.4.1.4SECTION 872.3100
   872.3100 Dental amalgamator.
21:8.0.1.1.23.4.1.5SECTION 872.3110
   872.3110 Dental amalgam capsule.
21:8.0.1.1.23.4.1.6SECTION 872.3130
   872.3130 Preformed anchor.
21:8.0.1.1.23.4.1.7SECTION 872.3140
   872.3140 Resin applicator.
21:8.0.1.1.23.4.1.8SECTION 872.3150
   872.3150 Articulator.
21:8.0.1.1.23.4.1.9SECTION 872.3165
   872.3165 Precision attachment.
21:8.0.1.1.23.4.1.10SECTION 872.3200
   872.3200 Resin tooth bonding agent.
21:8.0.1.1.23.4.1.11SECTION 872.3220
   872.3220 Facebow.
21:8.0.1.1.23.4.1.12SECTION 872.3240
   872.3240 Dental bur.
21:8.0.1.1.23.4.1.13SECTION 872.3250
   872.3250 Calcium hydroxide cavity liner.
21:8.0.1.1.23.4.1.14SECTION 872.3260
   872.3260 Cavity varnish.
21:8.0.1.1.23.4.1.15SECTION 872.3275
   872.3275 Dental cement.
21:8.0.1.1.23.4.1.16SECTION 872.3285
   872.3285 Preformed clasp.
21:8.0.1.1.23.4.1.17SECTION 872.3300
   872.3300 Hydrophilic resin coating for dentures.
21:8.0.1.1.23.4.1.18SECTION 872.3310
   872.3310 Coating material for resin fillings.
21:8.0.1.1.23.4.1.19SECTION 872.3330
   872.3330 Preformed crown.
21:8.0.1.1.23.4.1.20SECTION 872.3350
   872.3350 Gold or stainless steel cusp.
21:8.0.1.1.23.4.1.21SECTION 872.3360
   872.3360 Preformed cusp.
21:8.0.1.1.23.4.1.22SECTION 872.3400
   872.3400 Karaya and sodium borate with or without acacia denture adhesive.
21:8.0.1.1.23.4.1.23SECTION 872.3410
   872.3410 Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.
21:8.0.1.1.23.4.1.24SECTION 872.3420
   872.3420 Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive.
21:8.0.1.1.23.4.1.25SECTION 872.3450
   872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive.
21:8.0.1.1.23.4.1.26SECTION 872.3480
   872.3480 Polyacrylamide polymer (modified cationic) denture adhesive.
21:8.0.1.1.23.4.1.27SECTION 872.3490
   872.3490 Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
21:8.0.1.1.23.4.1.28SECTION 872.3500
   872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
21:8.0.1.1.23.4.1.29SECTION 872.3520
   872.3520 OTC denture cleanser.
21:8.0.1.1.23.4.1.30SECTION 872.3530
   872.3530 Mechanical denture cleaner.
21:8.0.1.1.23.4.1.31SECTION 872.3540
   872.3540 OTC denture cushion or pad.
21:8.0.1.1.23.4.1.32SECTION 872.3560
   872.3560 OTC denture reliner.
21:8.0.1.1.23.4.1.33SECTION 872.3570
   872.3570 OTC denture repair kit.
21:8.0.1.1.23.4.1.34SECTION 872.3580
   872.3580 Preformed gold denture tooth.
21:8.0.1.1.23.4.1.35SECTION 872.3590
   872.3590 Preformed plastic denture tooth.
21:8.0.1.1.23.4.1.36SECTION 872.3600
   872.3600 Partially fabricated denture kit.
21:8.0.1.1.23.4.1.37SECTION 872.3630
   872.3630 Endosseous dental implant abutment.
21:8.0.1.1.23.4.1.38SECTION 872.3640
   872.3640 Endosseous dental implant.
21:8.0.1.1.23.4.1.39SECTION 872.3645
   872.3645 Subperiosteal implant material.
21:8.0.1.1.23.4.1.40SECTION 872.3660
   872.3660 Impression material.
21:8.0.1.1.23.4.1.41SECTION 872.3661
   872.3661 Optical Impression Systems for CAD/CAM.
21:8.0.1.1.23.4.1.42SECTION 872.3670
   872.3670 Resin impression tray material.
21:8.0.1.1.23.4.1.43SECTION 872.3680
   872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials.
21:8.0.1.1.23.4.1.44SECTION 872.3690
   872.3690 Tooth shade resin material.
21:8.0.1.1.23.4.1.45SECTION 872.3710
   872.3710 Base metal alloy.
21:8.0.1.1.23.4.1.46SECTION 872.3730
   872.3730 Pantograph.
21:8.0.1.1.23.4.1.47SECTION 872.3740
   872.3740 Retentive and splinting pin.
21:8.0.1.1.23.4.1.48SECTION 872.3750
   872.3750 Bracket adhesive resin and tooth conditioner.
21:8.0.1.1.23.4.1.49SECTION 872.3760
   872.3760 Denture relining, repairing, or rebasing resin.
21:8.0.1.1.23.4.1.50SECTION 872.3765
   872.3765 Pit and fissure sealant and conditioner.
21:8.0.1.1.23.4.1.51SECTION 872.3770
   872.3770 Temporary crown and bridge resin.
21:8.0.1.1.23.4.1.52SECTION 872.3810
   872.3810 Root canal post.
21:8.0.1.1.23.4.1.53SECTION 872.3820
   872.3820 Root canal filling resin.
21:8.0.1.1.23.4.1.54SECTION 872.3830
   872.3830 Endodontic paper point.
21:8.0.1.1.23.4.1.55SECTION 872.3840
   872.3840 Endodontic silver point.
21:8.0.1.1.23.4.1.56SECTION 872.3850
   872.3850 Gutta percha.
21:8.0.1.1.23.4.1.57SECTION 872.3890
   872.3890 Endodontic stabilizing splint.
21:8.0.1.1.23.4.1.58SECTION 872.3900
   872.3900 Posterior artificial tooth with a metal insert.
21:8.0.1.1.23.4.1.59SECTION 872.3910
   872.3910 Backing and facing for an artificial tooth.
21:8.0.1.1.23.4.1.60SECTION 872.3920
   872.3920 Porcelain tooth.
21:8.0.1.1.23.4.1.61SECTION 872.3930
   872.3930 Bone grafting material.
21:8.0.1.1.23.4.1.62SECTION 872.3940
   872.3940 Total temporomandibular joint prosthesis.
21:8.0.1.1.23.4.1.63SECTION 872.3950
   872.3950 Glenoid fossa prosthesis.
21:8.0.1.1.23.4.1.64SECTION 872.3960
   872.3960 Mandibular condyle prosthesis.
21:8.0.1.1.23.4.1.65SECTION 872.3970
   872.3970 Interarticular disc prosthesis (interpositional implant).
21:8.0.1.1.23.4.1.66SECTION 872.3980
   872.3980 Endosseous dental implant accessories.
21:8.0.1.1.23.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.23.5.1.1SECTION 872.4120
   872.4120 Bone cutting instrument and accessories.
21:8.0.1.1.23.5.1.2SECTION 872.4130
   872.4130 Intraoral dental drill.
21:8.0.1.1.23.5.1.3SECTION 872.4200
   872.4200 Dental handpiece and accessories.
21:8.0.1.1.23.5.1.4SECTION 872.4465
   872.4465 Gas-powered jet injector.
21:8.0.1.1.23.5.1.5SECTION 872.4475
   872.4475 Spring-powered jet injector.
21:8.0.1.1.23.5.1.6SECTION 872.4535
   872.4535 Dental diamond instrument.
21:8.0.1.1.23.5.1.7SECTION 872.4565
   872.4565 Dental hand instrument.
21:8.0.1.1.23.5.1.8SECTION 872.4600
   872.4600 Intraoral ligature and wire lock.
21:8.0.1.1.23.5.1.9SECTION 872.4620
   872.4620 Fiber optic dental light.
21:8.0.1.1.23.5.1.10SECTION 872.4630
   872.4630 Dental operating light.
21:8.0.1.1.23.5.1.11SECTION 872.4730
   872.4730 Dental injecting needle.
21:8.0.1.1.23.5.1.12SECTION 872.4760
   872.4760 Bone plate.
21:8.0.1.1.23.5.1.13SECTION 872.4770
   872.4770 Temporary mandibular condyle reconstruction plate.
21:8.0.1.1.23.5.1.14SECTION 872.4840
   872.4840 Rotary scaler.
21:8.0.1.1.23.5.1.15SECTION 872.4850
   872.4850 Ultrasonic scaler.
21:8.0.1.1.23.5.1.16SECTION 872.4880
   872.4880 Intraosseous fixation screw or wire.
21:8.0.1.1.23.5.1.17SECTION 872.4920
   872.4920 Dental electrosurgical unit and accessories.
21:8.0.1.1.23.6SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.23.6.1.1SECTION 872.5410
   872.5410 Orthodontic appliance and accessories.
21:8.0.1.1.23.6.1.2SECTION 872.5470
   872.5470 Orthodontic plastic bracket.
21:8.0.1.1.23.6.1.3SECTION 872.5500
   872.5500 Extraoral orthodontic headgear.
21:8.0.1.1.23.6.1.4SECTION 872.5525
   872.5525 Preformed tooth positioner.
21:8.0.1.1.23.6.1.5SECTION 872.5550
   872.5550 Teething ring.
21:8.0.1.1.23.6.1.6SECTION 872.5560
   872.5560 Electrical salivary stimulatory system.
21:8.0.1.1.23.6.1.7SECTION 872.5570
   872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
21:8.0.1.1.23.6.1.8SECTION 872.5571
   872.5571 Auto titration device for oral appliances.
21:8.0.1.1.23.6.1.9SECTION 872.5580
   872.5580 Oral rinse to reduce the adhesion of dental plaque.
21:8.0.1.1.23.7SUBPART G
Subpart G - Miscellaneous Devices
21:8.0.1.1.23.7.1.1SECTION 872.6010
   872.6010 Abrasive device and accessories.
21:8.0.1.1.23.7.1.2SECTION 872.6030
   872.6030 Oral cavity abrasive polishing agent.
21:8.0.1.1.23.7.1.3SECTION 872.6050
   872.6050 Saliva absorber.
21:8.0.1.1.23.7.1.4SECTION 872.6070
   872.6070 Ultraviolet activator for polymerization.
21:8.0.1.1.23.7.1.5SECTION 872.6080
   872.6080 Airbrush.
21:8.0.1.1.23.7.1.6SECTION 872.6100
   872.6100 Anesthetic warmer.
21:8.0.1.1.23.7.1.7SECTION 872.6140
   872.6140 Articulation paper.
21:8.0.1.1.23.7.1.8SECTION 872.6200
   872.6200 Base plate shellac.
21:8.0.1.1.23.7.1.9SECTION 872.6250
   872.6250 Dental chair and accessories.
21:8.0.1.1.23.7.1.10SECTION 872.6290
   872.6290 Prophylaxis cup.
21:8.0.1.1.23.7.1.11SECTION 872.6300
   872.6300 Rubber dam and accessories.
21:8.0.1.1.23.7.1.12SECTION 872.6350
   872.6350 Ultraviolet detector.
21:8.0.1.1.23.7.1.13SECTION 872.6390
   872.6390 Dental floss.
21:8.0.1.1.23.7.1.14SECTION 872.6475
   872.6475 Heat source for bleaching teeth.
21:8.0.1.1.23.7.1.15SECTION 872.6510
   872.6510 Oral irrigation unit.
21:8.0.1.1.23.7.1.16SECTION 872.6570
   872.6570 Impression tube.
21:8.0.1.1.23.7.1.17SECTION 872.6640
   872.6640 Dental operative unit and accessories.
21:8.0.1.1.23.7.1.18SECTION 872.6650
   872.6650 Massaging pick or tip for oral hygiene.
21:8.0.1.1.23.7.1.19SECTION 872.6660
   872.6660 Porcelain powder for clinical use.
21:8.0.1.1.23.7.1.20SECTION 872.6670
   872.6670 Silicate protector.
21:8.0.1.1.23.7.1.21SECTION 872.6710
   872.6710 Boiling water sterilizer.
21:8.0.1.1.23.7.1.22SECTION 872.6730
   872.6730 Endodontic dry heat sterilizer.
21:8.0.1.1.23.7.1.23SECTION 872.6770
   872.6770 Cartridge syringe.
21:8.0.1.1.23.7.1.24SECTION 872.6855
   872.6855 Manual toothbrush.
21:8.0.1.1.23.7.1.25SECTION 872.6865
   872.6865 Powered toothbrush.
21:8.0.1.1.23.7.1.26SECTION 872.6870
   872.6870 Disposable fluoride tray.
21:8.0.1.1.23.7.1.27SECTION 872.6880
   872.6880 Preformed impression tray.
21:8.0.1.1.23.7.1.28SECTION 872.6890
   872.6890 Intraoral dental wax.