---
kind: "section"
citation: "21 C.F.R. § 874.3695"
title: "21"
number: "874.3695"
heading: "Mandibular implant facial prosthesis."
url: "https://uscodex.org/cfr/21/874.3695"
---

# §874.3695. Mandibular implant facial prosthesis.

- (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.

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.