Title 21: Food and Drugs
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/ PART 872 - DENTAL DEVICES
/ Subpart G - Miscellaneous Devices / § 872.6475 Heat source for bleaching teeth.
§ 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.