21 C.F.R. § 874.3695
Mandibular implant facial prosthesis.
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.