21 CFR 874.3695 — Prosthesis, Facial, Mandibular Implant

Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3695

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JAZProsthesis, Facial, Mandibular Implant22Implant
Innolitics

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