§ 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. 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 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] § 872.6030 Oral cavity abrasive polishing agent. (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. § 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 III. (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 872.3. [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. § 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. If the device is not labeled or otherwise represented as sterile, it is exempt from (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 duing dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting the tooth through the hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. (b) Classification. Class I. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. § 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. (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 13831, Apr. 5, 1989] § 872.6570 Impression tube. (a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth. The hollow tube is filled with impression material. One end of the tube is sealed with a softened material, such as wax, the remaining end is slipped over the tooth to make the impression. § 872.6670 Silicate protector. (a) Identification. A silicate protector is a device made of silicone intended to be applied with an absorbent tipped applicator to the surface of a new restoration to exclude temporarily fluids from its surface. Class I. (b) Classification. 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 13831, Apr. 5, 1989] § 872.6730 Endodontic dry heat sterilizer. (a) Identification. An endodontic dry heat sterilizer is a device intended to sterilize endodontic and other dental instruments by the application of dry heat. The heat is supplied through glass beads which have been heated by electricity. (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 872.3. § 872.6770 Cartridge syringe. (a) Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient. (b) Classification. Class II. § 872.6870 Disposable flouride tray. (a) Identification. A disposable fluoride tray is a device made of styrofoam intended to apply fluoride topically to the teeth. To use the tray, the patient bites down on the tray which has been filled with a fluoride solution. (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 13831, Apr. 5, 1989] § 872.6880 Preformed impression tray. (a) Identification. A preformed impression tray is a metal or plastic device intended to hold impression material, such as alginate, to make an impression of a patient's teeth or alveolar process (bony tooth sockets) to reproduce the structure of a patient's teeth and gums. (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 by 54 FR 13832, Apr. 5, 1989] § 872.6890 Intraoral dental wax. (a) Identification. Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth. (b) Classification. Class I. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. Subpart E-Surgical Devices 874.4100 Epistaxis balloon. 874.4140 Ear, nose, and throat bur. 874.4175 Nasopharyngeal catheter. 874.4250 Ear, nose, and throat electric or pneumatic surgical drill. 874.4350 Ear, nose, and throat fiberoptic light source and carrier. 874.4420 Ear, nose, and throat manual surgical instrument. 874.4490 Microsurgical argon laser. 874.4500 Ear, nose, and throat microsurgical carbon dioxide laser. 874.4680 Bronchoscope (flexible or rigid) and accessories. 874.4710 Esophagoscope (flexible or rigid) and accessories. 874.4720 Mediastinoscope and accessories. 874.4760 Nasopharyngoscope (flexible rigid) and accessories. Subpart F-Therapeutic Devices or 874.5220 Ear, nose, and throat drug administration device. 874.5350 Suction antichoke device. 874.5370 Tongs antichoke device. 874.5800 External nasal splint. 874.5840 Antistammering device. AUTHORITY: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371). SOURCE: 51 FR 40389, Nov. 6, 1986, unless otherwise noted. Subpart A-General Provisions § 874.1 Scope. (a) This part sets forth the classification of ear, nose, and throat devices |