StacksVerified U.S. regulatory reference

21 CFR §872.4630

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.
  2. (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.