21 C.F.R. § 872.4630 Dental operating light.
Title 21 - Food and Drugs
(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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38799, July 25, 2001]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart E—Surgical Devices
§ 872.4630 Dental operating light.
