Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3695](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3695) → JAZ — Prosthesis, Facial, Mandibular Implant

# JAZ · Prosthesis, Facial, Mandibular Implant

_Ear, Nose, Throat · 21 CFR 874.3695 · Class 2_

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

## Overview

- **Product Code:** JAZ
- **Device Name:** Prosthesis, Facial, Mandibular Implant
- **Regulation:** [21 CFR 874.3695](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3695)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)
- **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](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JAZ/K901923.md) | INVOTEC POLY-MESH MANDIBULAR TRAY | Invotec International, Inc. | Oct 31, 1990 | SESE |
| [K821904](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JAZ/K821904.md) | XOMED MANDIBULAR TRAY | Xomed, Inc. | Jul 26, 1982 | SESE |

## Top Applicants

- Invotec International, Inc. — 1 clearance
- Xomed, Inc. — 1 clearance

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

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