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51 FR 40389, Nov. 6, 1986, unless otherwise noted.
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Subscribe to: 21 CFR 874.3695
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Nomenclature changes to part 874 appear at 73 FR 35341, June 23, 2008.
(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.