21 CFR § 874.3695 Ear, Nose, and Throat Devices

§ 874.3695 Mandibular implant facial prosthesis.

Current through Sep 8, 2026 · Read all of Part 874

(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.

← § 874.3620 Ear, nose, and throat synthetic polymer material.§ 874.3730 Laryngeal prosthesis (Taub design). →