Mandibular implant facial prosthesis.

21 C.F.R. § 874.3695
in effectEffective: 2024-07-01
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(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.

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