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GDC-685

by Deringer-Ney, Inc.

510(k) K790641

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 NumberK790641 Date1 May 1979ClearedStatusActive

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  • Withdrawn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
EJS
Device Class
Class II
Regulation
21 CFR Part 872.3060
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The GDC-685 is an alloy, other noble metal device. It is classified as a class 2 device.

The GDC-685 is supplied by Deringer-Ney, Inc. and has FDA 510K authorizations. It is used in the dental medical specialty and is regulated under regulation number 872.3060.

Other devices from Deringer-Ney, Inc.

See all devices from Deringer-Ney, Inc. →

Questions

AI-generated answers, 26 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 the GDC-685 device used for?

    The GDC-685 is used in the dental medical specialty, indicating its application in dental procedures and treatments.

  • Is the GDC-685 device regulated?

    Yes, the GDC-685 is regulated under regulation number 872.3060, and it has received FDA 510K authorizations, indicating its compliance with specific standards.

  • What type of device is the GDC-685?

    The GDC-685 is classified as a class 2 device, which is a moderate-risk device that requires more stringent controls than class 1 devices but less than class 3 devices.