§ 872.6640. Dental operative unit and accessories.
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/us/cfr/t21/s§ 872.6640·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]