21 CFR § 874.3695 - Mandibular implant facial prosthesis.

---
identifier: "/us/cfr/t21/s874.3695"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3695 - Mandibular implant facial prosthesis."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3695"
section_name: "Mandibular implant facial prosthesis."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "874"
part_name: "EAR, NOSE, AND THROAT DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "51 FR 40389, Nov. 6, 1986, unless otherwise noted."
cfr_part: "874"
---


# 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.