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21 C.F.R. § 872.6475   Heat source for bleaching teeth.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart G—Miscellaneous Devices

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§ 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.

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

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