e-CFR data is current as of March 2, 2021 |
Title 21 → Chapter I → Subchapter H → Part 872 → Subpart E → §872.4620 |
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart E—Surgical Devices
(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]