21 C.F.R. § 874.3695

Current through October 31, 2024
Section 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.

21 C.F.R. § 874.3695