21 CFR 872.4620 — Light, Fiber Optic, Dental

Dental (DE) · Subpart E—Surgical Devices · § 872.4620

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
EAYLight, Fiber Optic, Dental118
Innolitics

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