Argenco 60 Type IV Dental Gold Alloy

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K893554 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Argedent 45

  Class II

  FDA 510(k) K892814 Active Cleared 22 May 1989

• Surefire W

  Class II

  FDA 510(k) K940342 Active Cleared 4 Mar 1994

• Argistar 72 (High Gold Platinum Silver Alloy for Both Low Fusing Porcelain and Crown and Bridge Application

  Class II

  FDA 510(k) K935973 Active Cleared 28 Jan 1994

• Argedent 62 Dental Alloy

  Class II

  FDA 510(k) K892709 Active Cleared 1 Jun 1989

• Argeloy N.P. (V) (Non-Precious Dental Alloy for Procelain Application)

  Class II

  FDA 510(k) K935972 Active Cleared 26 Jan 1994

• Argebond 77+

  Class II

  FDA 510(k) K915165 Active Cleared 21 Apr 1992

See all devices from Argen Precious Metals, Inc. →

• What types of dental restorations is the Argenco 60 Type IV Dental Gold Alloy specifically designed for?

  The Argenco 60 Type IV Dental Gold Alloy is specifically formulated for use in dental crowns and bridges. It is a gold-based noble metal alloy intended to provide durable, long-lasting restorations with biocompatible properties, making it suitable for these common dental applications.

• Is the Argenco 60 Type IV Dental Gold Alloy intended for single-use or reusable applications?

  The Argenco 60 Type IV Dental Gold Alloy is supplied as a reusable dental material, meaning it is designed for use in dental laboratories and clinical settings where the alloy can be melted, reshaped, and reused for multiple restorations. This makes it cost-effective for high-volume dental work.

• What regulatory standards does the Argenco 60 Type IV Dental Gold Alloy comply with, and how was its approval process handled?

  The Argenco 60 Type IV Dental Gold Alloy complies with the mechanical and thermal properties defined by the standard BS EN ISO 22674. Its regulatory pathway involved a Traditional 510(k) clearance through the FDA, filed under the Dental (DE) Advisory Committee in 1989. The decision was classified as Substantially Equivalent (SESE), confirming its compliance with existing dental alloy standards.

• How is the Argenco 60 Type IV Dental Gold Alloy categorized in regulatory databases, and what does this indicate about its intended use?

  The Argenco 60 Type IV Dental Gold Alloy is categorized under FDA Product Code EJT and Regulation Number 872.3060, which pertains to dental restorative materials. This classification confirms its intended use as a dental restorative alloy for crowns and bridges, rather than for general medical or surgical applications. The medical specialty description in regulatory databases also explicitly lists it under Dental, reinforcing its purpose.