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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 872 - Dental Devices |
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Subpart G - Miscellaneous Devices |
§ 872.6475 - Heat source for bleaching teeth.
Latest version.
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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]