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Agc-Gold Electrolyte For Agc-Micro, Agc-Gold Electrolyte For Agc-Speed, Agc-Goldbonder, Agc Glavanogold

by Wieland Edelmetalle GmbH & Co.

510(k) K001041

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 NumberK001041 Date23 May 2000ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The Agc-Gold Electrolyte is a noble metal alloy device composed primarily of gold, intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations. It is a type of alloy used in dental applications.

The device is supplied by Wieland Edelmetalle GmbH & Co. and has FDA 510K clearance with the regulation number 872.3060. The product code is EJT and it is classified as a device with a medical specialty description of Dental.

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Questions

AI-generated answers, 6 Oct 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 the Agc-Gold Electrolyte used for?

    The Agc-Gold Electrolyte is used in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations in dental applications.

  • What is the composition of the Agc-Gold Electrolyte?

    The Agc-Gold Electrolyte is a noble metal alloy device composed primarily of gold.

  • Is the Agc-Gold Electrolyte supplied sterile?

    The description does not specify if the Agc-Gold Electrolyte is supplied sterile, it is recommended to consult the manufacturer for this information.

  • What is the regulatory classification of the Agc-Gold Electrolyte?

    The Agc-Gold Electrolyte has a product code of EJT and is classified as a device with a medical specialty description of Dental.