21 C.F.R. § 872.6640 Dental operative unit and accessories.
Title 21 - Food and Drugs
(a) Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair. (b) Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to §872.9. [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 65 FR 2315, Jan. 14, 2000]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart G—Miscellaneous Devices
§ 872.6640 Dental operative unit and accessories.
