Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 874  /  Sec. 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.