21 C.F.R. § 872.4120
Bone cutting instrument and accessories.
Cite as 21 C.F.R. § 872.4120 (2026)
(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.