Title 21: Food and Drugs
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/ PART 872 - DENTAL DEVICES
/ Subpart E - Surgical Devices / § 872.4120 Bone cutting instrument and accessories.
§ 872.4120 Bone cutting instrument and accessories.
(a) Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.
(b) Classification. Class II.