C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 874—EAR, NOSE, AND THROAT DEVICES › Subpart D—Prosthetic Devices

21 C.F.R. § 874.3695

Mandibular implant facial prosthesis

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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.

Notes of Decisions
Cited in 2 cases, 1995–1996 · leading case: Anguiano v. E.I. Du Pont de Nemours & Co., 44 F.3d 806 (9th Cir. 1995).
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Anguiano v. E.I. Du Pont de Nemours & Co., 44 F.3d 806 (9th Cir. 1995). “3680 , mandibular implant facial prosthesis, 21 C.F.R. § 874.3695 , and PTFE with carbon fibers composite implant material, 21 C.”
Kealoha v. E.I. du Pont de Nemours & Co., 82 F.3d 894 (9th Cir. 1996). “3680 ,- mandibular implant facial prosthesis, 21 C.F.R. § 874.3695 , and PTFE with carbon fibers composite implant material, 21 C.”
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