13530458900

FDA medical devices classification list

TITLE 21--FOOD AND DRUGS
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.
   § 872.5580 - Oral rinse to reduce the adhesion of dental plaque.

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 fluoride tray.
   § 872.6880 - Preformed impression tray.
   § 872.6890 - Intraoral dental wax.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

Extracted from US.FDA