← Product Code [JAZ](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JAZ) · K821904

# XOMED MANDIBULAR TRAY (K821904)

_Xomed, Inc. · JAZ · Jul 26, 1982 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JAZ/K821904

## Device Facts

- **Applicant:** Xomed, Inc.
- **Product Code:** [JAZ](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JAZ.md)
- **Decision Date:** Jul 26, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3695
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JAZ/K821904](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JAZ/K821904)

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