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Code · CFR · Title 21 — Food and Drugs · Part 872 — Dental Devices · § 872.4620

§ 872.4620. Fiber optic dental light.

98 words·~1 min read·/us/cfr/t21/s§ 872.4620·

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(a)Identification. A fiber optic dental light is a device that is a light, usually AC-powered, that consists of glass or plastic fibers which have special optical properties. The device is usually attached to a dental handpiece and is intended to illuminate a patient's oral structures.
(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 63008, Dec. 7, 1994; 66 FR 38799, July 25, 2001]
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