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Cera F Alloy

by Dentsply International

510(k) K032321

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 NumberK032321 Date30 Sep 2003ClearedStatusActive

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  • Withdrawn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
EJT
Device class
Class II
Regulation
21 CFR Part 872.3060
Advisory committee
Dental
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.

Cera F Alloy is a dental alloy classified as a gold-based noble metal. It is designed for use in dental applications and is manufactured by Dentsply International.

The device is supplied as a Class II product with special controls under regulation number 872.3060. It received FDA 510(k) clearance on September 30, 2003, with the K032321 number, and is manufactured in York, Pennsylvania.

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Questions

AI-generated answers, 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.

  • What is Cera F Alloy used for?

    Cera F Alloy is used in dental applications, specifically as a gold-based noble metal alloy.

  • Is Cera F Alloy supplied sterile?

    The description does not specify if Cera F Alloy is supplied sterile, but it is classified as a Class II product with special controls.

  • What is the regulatory status of Cera F Alloy?

    Cera F Alloy received FDA 510(k) clearance on September 30, 2003, with the K032321 number, under regulation number 872.3060.

  • Where is Cera F Alloy manufactured?

    Cera F Alloy is manufactured by Dentsply International in York, Pennsylvania.