JAZ · Prosthesis, Facial, Mandibular Implant
Ear, Nose, Throat · 21 CFR 874.3695 · Class 2
Overview
| Product Code | JAZ |
|---|---|
| Device Name | Prosthesis, Facial, Mandibular Implant |
| Regulation | 21 CFR 874.3695 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K901923 | INVOTEC POLY-MESH MANDIBULAR TRAY | Invotec International, Inc. | Oct 31, 1990 | SESE |
| K821904 | XOMED MANDIBULAR TRAY | Xomed, Inc. | Jul 26, 1982 | SESE |
Top Applicants
- Invotec International, Inc. — 1 clearance
- Xomed, Inc. — 1 clearance
