Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3620](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3620) → ESH — Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane

# ESH · Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane

_Ear, Nose, Throat · 21 CFR 874.3620 · Class 2_

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

## Overview

- **Product Code:** ESH
- **Device Name:** Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
- **Regulation:** [21 CFR 874.3620](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3620)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)
- **Implant:** yes

## Identification

Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K771615](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESH/K771615.md) | AUDI-SIL EARMOLD MATERIAL | Coe Laboratories, Inc. | Aug 30, 1977 | SESE |

## Top Applicants

- Coe Laboratories, Inc. — 1 clearance

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

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