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SOLDER GPY

by Gateway Alloys, Inc.

510(k) K964705

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 NumberK964705 Date16 Dec 1996ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

SOLDER GPY is an alloy, other noble metal device classified under product code EJS and regulation number 872.3060. It is a Class 2 dental device that received FDA 510(k) clearance as substantially equivalent through the traditional pathway.

The device was manufactured by Gateway Alloys, Inc. and received clearance on December 16, 1996, under K964705. It is intended for use in dental applications as indicated by its classification and advisory committee designation.

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Questions

AI-generated answers, 1 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 SOLDER GPY used for?

    SOLDER GPY is intended for use in dental applications, as indicated by its classification under product code EJS and regulation number 872.3060, and its advisory committee designation for dental use.

  • How was SOLDER GPY cleared for market?

    SOLDER GPY received FDA 510(k) clearance through the traditional pathway as substantially equivalent (SESE) under K964705, based on its classification as a Class 2 dental device.

  • Who manufactures SOLDER GPY and when was it cleared?

    SOLDER GPY was manufactured by Gateway Alloys, Inc. and received FDA 510(k) clearance on December 16, 1996, under submission K964705.