XOMED MANDIBULAR TRAY
Device Facts
| Record ID | K821904 |
|---|---|
| Device Name | XOMED MANDIBULAR TRAY |
| Applicant | Xomed, Inc. |
| Product Code | JAZ · Ear, Nose, Throat |
| Decision Date | Jul 26, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3695 |
| Device Class | Class 2 |
Regulatory Classification
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.
