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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 872.4120: Bone cutting instrument and accessories.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER H—MEDICAL DEVICES
  4. PART 872—DENTAL DEVICES
  5. Subpart E—Surgical Devices

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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