Code of Federal Regulations Title 21. Food and Drugs § 21.872.6640 Dental operative unit and accessories

(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.