Skip to content

Audi-Sil Earmold Material

by Coe Laboratories, Inc.

510(k) K771615

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK771615 Date30 Aug 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ESH
Device Class
Class II
Regulation
21 CFR Part 874.3620
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Audi-Sil Earmold Material is a polymer-based ear, nose, and throat device classified as a synthetic silicone elastomer, polyethylene, and polyurethane material. It is intended for use in the fabrication of custom earmolds for hearing aids and related audiological applications.

The device is supplied as a non-sterile, reusable material for professional use in clinical or laboratory settings. It has received FDA 510(k) clearance (K771615) and is classified as a Class II medical device under regulation 874.3620 with product code ESH. No information regarding MRI safety, specific sizes, or storage conditions is provided in the data.

Other devices from Coe Laboratories, Inc.

See all devices from Coe Laboratories, Inc. →