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Argenco 25

by Argen Precious Metals, Inc.

510(k) K903549

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 NumberK903549 Date6 Sep 1990ClearedStatusActive

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  • Withdrawn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, 19 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 Argenco 25 is a gold-based noble metal alloy designed for dental casting applications. It is classified as a dental alloy under FDA’s product code EJT and regulation number 872.3060, intended for use in dental restorative procedures requiring high-strength, biocompatible materials.

This alloy is supplied in a non-sterile, reusable form and is intended for use in dental laboratories. It adheres to the ISO 22674 standard for dental casting alloys. The device holds an FDA 510(k) clearance (K903549) under a traditional review pathway, classified as a Class II medical device. No MRI safety information or single-use designation is specified.

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