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Argesol #650

by Argen Precious Metals, Inc.

510(k) K942978

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 NumberK942978 Date22 Jul 1994ClearedStatusActive

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  • Withdrawn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.

Argesol #650 is a gold-based noble metal alloy classified as a dental solder. It is designed for use with high noble, noble crown and bridge, and porcelain fused to metal alloys.

This product is supplied as a yellow solder with a flow temperature of 800 degrees Celsius. It has received FDA 510(k) clearance.

Other devices from Argen Precious Metals, Inc.

See all devices from Argen Precious Metals, Inc. →

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 primary use of Argesol #650?

    Argesol #650 is a gold-based noble metal alloy specifically formulated as a dental solder. It is intended for use in joining high noble, noble crown and bridge, and porcelain fused to metal alloys.

  • What are the physical characteristics and flow temperature of this solder?

    This product is supplied as a yellow solder material. It is designed to be used with a flow temperature of 800 degrees Celsius to ensure proper bonding with compatible dental alloys.

  • What is the regulatory status of Argesol #650?

    Argesol #650 has received FDA 510(k) clearance, which indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.