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) → ESF — Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent

# ESF · Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent

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

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

## Overview

- **Product Code:** ESF
- **Device Name:** Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K891247](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESF/K891247.md) | BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC | Siemens Hearing Instruments, Inc. | Mar 29, 1989 | SESE |
| [K813224](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESF/K813224.md) | CERAVITAL CERAMIC EAR CANAL WALL PROSTH | Xomed, Inc. | Apr 21, 1982 | SESE |

## Top Applicants

- Xomed, Inc. — 1 clearance
- Siemens Hearing Instruments, Inc. — 1 clearance

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

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