GroundRules
21 CFR 874.3695: Mandibular implant facial prosthesis.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 874—EAR, NOSE, AND THROAT DEVICES
- Subpart D—Prosthetic Devices
(a) Identification. A mandibular implant facial prosthesis is a device that is intended to be implanted for use in the functional reconstruction of mandibular deficits. The device is made of materials such as stainless steel, tantalum, titanium, cobalt-chromium based alloy, polytetrafluoroethylene, silicone elastomer, polyethylene, polyurethane, or polytetrafluoroethylene with carbon fibers composite.
(b) Classification. Class II.
Collected 2026-08-27T02:24:47Z. Source file · JSON