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Argedent 74 Dental Alloy For Porcelain Appli

by Argen Precious Metals, Inc.

510(k) K892335

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 NumberK892335 Date31 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  • Withdrawn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, 22 Sep 2026

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

Argedent 74 is a gold‑based noble metal alloy classified as a dental alloy. It is formulated for use in porcelain‑fused‑to‑metal restorations, providing the strength and esthetic compatibility required for fixed prosthetic applications.

The alloy is marketed by Argen Precious Metals, Inc. of San Diego, California, and has received FDA 510(k) clearance (K892335) under product code EJT, class II with special controls. It is supplied as a castable material for dental laboratory use and is stored according to the manufacturer’s specifications.

Other devices from Argen Precious Metals, Inc.

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Questions

AI-generated answers, 22 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 clinical applications is ARGEDENT 74 intended for?

    ARGEDENT 74 is formulated specifically for porcelain‑fused‑to‑metal (PFM) fixed prosthetic restorations. The gold‑based composition provides the strength and esthetic compatibility needed to support porcelain layering on metal substructures in crowns and bridges.

  • How is the alloy provided to dental laboratories?

    The alloy is supplied as a castable material, meaning it is delivered in a form that can be melted and poured into molds by the dental lab. This allows technicians to fabricate custom PFM frameworks that match each patient’s anatomy.

  • Is ARGEDENT 74 a sterile, single‑use product?

    ARGEDENT 74 is not marketed as a sterile, single‑use item. It is a bulk alloy intended for casting in a controlled laboratory environment, where standard infection‑control practices are applied during processing.

  • What regulatory pathway did ARGEDENT 74 follow?

    The device received FDA 510(k) clearance (K892335) under product code EJT, class II with special controls. This indicates it was found substantially equivalent to a legally marketed predicate device and is cleared for its intended dental alloy use.