21 C.F.R. § 874.3695

Mandibular implant facial prosthesis.

Last amended: 2016Year: 2026Length: 55 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 874.3695 (2026)

(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.
21 C.F.R. § 874.3695: Mandibular implant facial prosthesis. | Justis AI