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Development No. 647

by Deringer-Ney, Inc.

510(k) K790414

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 NumberK790414 Date10 Apr 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  • Withdrawn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
EJT
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.

This device is an alloy, gold-based noble metal, classified under the dental specialty. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

It was manufactured by Deringer-Ney, Inc., received on February 26, 1979, and cleared on April 10, 1979, under K790414. The device is authorized for use in the United States and is associated with multiple FEI numbers and registration numbers as specified in the openFDA data.

Other devices from Deringer-Ney, Inc.

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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 DEVELOPMENT NO. 647 used for?

    DEVELOPMENT NO. 647 is a gold-based noble metal alloy device classified under the dental specialty, intended for use in dental applications as a substantially equivalent product cleared through the FDA 510(k) pathway.

  • How is DEVELOPMENT NO. 647 supplied or manufactured?

    DEVELOPMENT NO. 647 was manufactured by Deringer-Ney, Inc. at their facility located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, and received for review on February 26, 1979.

  • What regulatory pathway was used for DEVELOPMENT NO. 647?

    DEVELOPMENT NO. 647 was cleared through the traditional 510(k) pathway as a substantially equivalent device, with clearance granted on April 10, 1979, under K number K790414.