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Ceramco Crowns and Bridges

by Asap Dental Lab, Ltd.

510(k) K926165

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK926165 Date31 Mar 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
EJH
Device Class
Class II
Regulation
21 CFR Part 872.3710
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

Ceramco Crowns and Bridges are dental prosthetic devices used to restore damaged or missing teeth. These devices are designed to fit over existing teeth or replace missing teeth by bridging the gap between them.

The device is supplied as a dental restoration and is intended for use in dental procedures. It is regulated under FDA 510K clearance with product code EJH and is classified as a Class II device. The device is manufactured by Asap Dental Lab, Ltd. and is available in various sizes and models as specified by the manufacturer.

Questions

AI-generated answers, 23 Sep 2026

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

  • What are Ceramco Crowns and Bridges used for?

    Ceramco Crowns and Bridges are dental prosthetic devices designed to restore damaged or missing teeth. They fit over existing teeth or bridge gaps between missing teeth to restore dental function and appearance.

  • How are Ceramco Crowns and Bridges supplied?

    The device is supplied as a dental restoration intended for use in dental procedures. It is manufactured by Asap Dental Lab, Ltd. and is available in various sizes and models as specified by the manufacturer.

  • What is the regulatory status of Ceramco Crowns and Bridges?

    Ceramco Crowns and Bridges are regulated under FDA 510K clearance with product code EJH and are classified as a Class II device. They received FDA clearance in 1994 with the K number K926165.

  • Are Ceramco Crowns and Bridges reusable or single-use devices?

    The device information does not specify whether Ceramco Crowns and Bridges are designed for single-use or multiple reuse. This detail would be determined by the dental professional based on clinical guidelines and manufacturer recommendations.