§ 874.3695. Mandibular implant facial prosthesis.
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/us/cfr/t21/s§ 874.3695·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.