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Argelite 60

by Argen Precious Metals, Inc.

510(k) K892813

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 NumberK892813 Date19 May 1989ClearedStatusActive

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  • Withdrawn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, 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.

The Argelite 60 is a gold-based noble metal alloy designed for dental applications. It is classified as a dental alloy and is composed primarily of palladium and silver, offering enhanced strength and biocompatibility for use in ceramic veneering materials. This alloy is engineered to provide a durable and aesthetically pleasing solution in restorative dentistry.

Argelite 60 is supplied as a reusable dental material and is intended for use in clinical dental settings. The product is regulated under FDA 510(k) clearance (K892813) and falls under the classification of Class II medical devices (EJT). It adheres to regulatory standards for dental alloys, ensuring safety and performance in dental procedures. Storage and handling follow standard dental material protocols.

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