Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3500](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3500) → ODU — Facial Implant

# ODU · Facial Implant

_General, Plastic Surgery · 21 CFR 878.3500 · Class 2_

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

## Overview

- **Product Code:** ODU
- **Device Name:** Facial Implant
- **Regulation:** [21 CFR 878.3500](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3500)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K071823](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ODU/K071823.md) | PERMA FACIAL IMPLANTS | Surgisil | Sep 19, 2007 | SESE |

## Top Applicants

- Surgisil — 1 clearance

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

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