Argenco 7A

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

510(k) Number

K903118 ↗

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 procedures is the Argenco 7A gold-based noble metal alloy intended for?

  The Argenco 7A is specifically designed for dental restorative and prosthetic work that requires a high noble metal content. This includes applications like crowns, bridges, inlays, onlays, and other fixed dental prosthetics where durability and biocompatibility are critical. Its classification under FDA’s dental alloy category ensures it meets standards for these uses.

• Is the Argenco 7A reusable or single-use, and how is it supplied?

  The Argenco 7A is supplied as a reusable material for dental fabrication, meaning it is intended to be melted down, reshaped, and reused in multiple dental restorations. It adheres to the international standard BS EN ISO 22674, ensuring consistent quality and performance across uses. It is not pre-formed for single-use applications like implants or temporary restorations.

• What regulatory pathway was followed for FDA clearance of the Argenco 7A, and what does that mean for its use?

  The Argenco 7A received FDA clearance through a 510(k) premarket notification with a traditional review pathway, meaning its safety and effectiveness were compared to a legally marketed predicate device. This clearance confirms it meets FDA standards for dental alloys under 21 CFR 872.3060, ensuring it is suitable for restorative and prosthetic dental applications requiring high noble metal content. The product code EJT further categorizes it under the Dental Advisory Committee’s classification.

• Are there specific storage requirements for the Argenco 7A alloy?

  While the provided data does not explicitly detail storage conditions, gold-based noble metal alloys like Argenco 7A are typically stored in a dry, clean environment to prevent contamination or oxidation. Since it is reusable, it should be kept in a sealed container or packaging to maintain its purity and prevent cross-contamination with other materials. Always follow manufacturer guidelines for optimal handling.