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TITLE 21--FOOD AND DRUGS
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
§ 872.3050 -
Amalgam alloy.
§ 872.3060 -
Gold-based alloys and precious metal alloys for clinical use.
§ 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.
§ 872.3700 - Dental mercury.
§ 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 -
Tricalcium phosphate granules for dental bone repair.
§ 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.
§ 872.4840 - 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.
§
872.5570 - Intraoral devices for snoring and intraoral devices for snoring
and obstructive sleep apnea.
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 flouride tray.
§
872.6880 - Preformed impression tray.
§ 872.6890 - Intraoral dental wax.
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