Subpart E-Surgical Devices

§ 872.4120 Bone cutting instrument and accessories.

(a) Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw. (b) Classification. Class II.

§ 872.4130 Intraoral dental drill.

(a) Identification. An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to secure cast or preformed pins to retain operative dental appliances.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994]

§ 872.4200 Dental handpiece and accessories.

(a) Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or beltdriven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. (b) Classification. Class I. [55 FR 48439, Nov. 20, 1990]

§872.4465 Gas-powered jet injector.

(a) Identification. A gas-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a cartridge containing pressurized carbon dioxide which provides the pressure to force the anesthetic out of the syringe. (b) Classification. Class II.

§ 872.4475 Spring-powered jet injector. (a) Identification. A spring-powered jet injector is a syringe device intended

to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe. (b) Classification. Class II.

§ 872.4535 Dental diamond instrument. (a) Identification. A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation of the diamond instrument provides an abrasive action when it contacts a tooth.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12. 1987, as amended at 59 FR 63008, Dec. 7, 1994]

§ 872.4565 Dental hand instrument.

(a) Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument,

dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.

(b) Classification. Class I. If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989]

§ 872.4600 Intraoral ligature and wire lock.

(a) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.

(b) Classification. Class II.

§ 872.4620 Fiber optic dental light.

(a) Identification. A fiber optic dental light is a device that is a light, usually AC-powered, that consists of glass or plastic fibers which have special optical properties. The device is usually attached to a dental handpiece and is intended to illuminate a patient's oral structures.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994]

§ 872.4630 Dental operating light.

(a) Identification. A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating

areas.

(b) Classification. Class I. The device is exempt from the premarket notifica

tion procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996]

§ 872.4730 Dental injecting needle.

(a) Identification. A dental injecting needle is a slender, hollow metal device with a sharp point intended to be attached to a syringe to inject local anesthetics and other drugs.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994]

§ 872.4760 Bone plate.

(a) Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

(b) Classification. Class II.

§ 872.4840 Rotary scaler.

(a) Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy.

(b) Classification. Class II.

§ 872.4850 Ultrasonic scaler.

(a) Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth. (b) Classification. Class II.

§ 872.4880 Intraosseous fixation screw or wire.

(a) Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

(b) Classification. Class II.

an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue. (b) Classification. Class II.

Subpart F-Therapeutic Devices

§ 872.5410 Orthodontic appliance and accessories.

(a) Identification. An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994]

§ 872.5470 Orthodontic plastic bracket. (a) Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position. (b) Classification. Class II.

§ 872.5500 Extraoral orthodontic headgear.

(a) Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.

(b) Classification. Class II.

§ 872.5525 Preformed tooth positioner.

(a) Identification. A preformed tooth positioner is a plastic device that is an impression of a perfected bite intended to prevent a patient's teeth from shifting position or to move teeth to a final position after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994]

§ 872.5550 Teething ring.

(a) Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.

(b)(1) Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

(2) Class II if the teething ring contains a fluid, such as water.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994]

Subpart G-Miscellaneous Devices

§ 872.6010 Abrasive device and accessories.

(a) Identification. An abrasive device and accessories is a device constructed of various abrasives, such as diamond chips, that are glued to shellac-based paper. The device is intended to remove excessive restorative materials, such as gold, and to smooth rough surfaces from oral restorations. such as crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive disk, guard for an abrasive disk, abrasive point, polishing agent strip, and polishing wheel.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807

(a) Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994]

§ 872.6050 Saliva absorber.

(a) Identification. A saliva absorber is a device made of paper or cotton intended to absorb moisture from the oral cavity during dental procedures.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of § 820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989]

§ 872.6070 Ultraviolet activator for polymerization.

(a) Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

(b) Classification. Class II.

§ 872.6080 Airbrush.

(a) Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

(b) Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, "Medical Electrical Equipment-Part 1: General Requirements for Safety.” [52 FR 30097, Aug. 12, 1987; 52 FR 49250, Dec. 30, 1987]

§ 872.6100 Anesthetic warmer.

(a) Identification. An anesthetic warmer is an AC-powered device into which tubes containing anesthetic solution are intended to be placed to warm them prior to administration of the anesthetic.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 60 FR 38900, July 28, 1995]

§ 872.6140 Articulation paper.

(a) Identification. Articulation paper is a device composed of paper coated with an ink dye intended to be placed between the patient's upper and lower teeth when the teeth are in the bite position to locate uneven or high areas.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994]

§ 872.6200 Base plate shellac.

(a) Identification. Base plant shellac is a device composed of shellac intended to rebuild the occlusal rim of full or partial dentures.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12. 1987, as amended at 54 FR 13830, Apr. 5, 1989]

§ 872.6250 Dental chair and accessories.

(a) Identification. A dental chair and accessories is a device, usually ACpowered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.

(b) Classification. Class I. The dental chair without the operative unit device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994]

§ 872.6290 Prophylaxis cup.

(a) Identification. A prophylaxis cup is a device made of rubber intended to be held by a dental handpiece and used to apply polishing agents during prophylaxis (cleaning). The dental handpiece spins the rubber cup holding the polishing agent and the user applies it to the teeth to remove debris.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise respresented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of §820.180, with respect to general requirements concerning

records, and § 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989]

§872.6300 Rubber dam and accessories.

(a) Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and §820.198 of this chapter, with respect to complaint files.

[65 FR 2315, Jan. 14, 2000]

§ 872.6350 Ultraviolet detector.

(a) Identification. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.

(b) Classification. Class II.

$872.6390 Dental floss.

(a) Identification. Dental floss is a string-like device made of cotton or other fibers intended to remove plaque and food particles from between the teeth to reduce tooth decay. The fibers of the device may be coated with wax for easier use.