21 C.F.R. § 872.6475

Current through October 31, 2024
Section 872.6475 - Heat source for bleaching teeth
(a)Identification. A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.
(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 .

21 C.F.R. §872.6475

55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799 , July 25, 2001