Argenco 19

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

510(k) Number

K904437 ↗

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 19 alloy specifically designed for?

  The Argenco 19 is a gold-based noble metal alloy intended for dental restorations such as crowns, bridges, inlays, and onlays. Its design prioritizes biocompatibility and durability, making it suitable for applications where long-term stability and patient tolerance are critical.

• Is the Argenco 19 alloy reusable or single-use, and how should it be handled?

  The Argenco 19 is supplied as a reusable dental alloy, meaning it is intended for repeated use in clinical settings after proper cleaning and processing. Since it is not sterile by default, it must be sterilized between uses following standard dental sterilization protocols to ensure safety and prevent contamination.

• What regulatory pathway was followed for FDA clearance, and what does that mean for its use?

  The Argenco 19 was cleared through the Traditional 510(k) pathway in 1990 under FDA clearance number K904437, classified as a Class 2 dental product with product code EJT. This means it was determined to be substantially equivalent to a legally marketed predicate device and is intended for use in clinical dental settings as a restorative material for crowns, bridges, inlays, and onlays.

• Are there any special storage requirements for the Argenco 19 alloy?

  The provided data does not specify unique storage conditions beyond what is standard for dental alloys. However, since it is reusable, it should be stored in a clean, dry environment to prevent contamination or degradation before use. Always follow manufacturer guidelines for handling and storage to maintain its integrity and performance.