Argelite A

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

510(k) Number

K934773 ↗

FDA Product Code

EJS

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 is Argelite A used for in dental applications?

  Argelite A is a dental alloy designed specifically for use in restorations, particularly where high strength and biocompatibility are required. Its primary composition of palladium and silver makes it ideal for ceramic veneering applications, ensuring durability and aesthetic compatibility with ceramic materials. This alloy is engineered to meet the mechanical demands of dental prosthetics, providing a reliable foundation for long-lasting restorations.

• Is Argelite A sterile by design?

  No, Argelite A is not sterile by design. It is supplied as a reusable dental alloy intended for professional use in dental laboratories and clinics. When used in direct patient care, it must undergo appropriate sterilization protocols to ensure safety and compliance with clinical standards.

• How is Argelite A supplied and what are its regulatory requirements?

  Argelite A is supplied as a reusable alloy, meaning it is intended for multiple uses after proper cleaning and sterilization. It is classified under Dental Device Class II and has received FDA 510(k) clearance (K934773), confirming its substantial equivalence to a predicate device. Its use is regulated under 21 CFR 872.3060, which outlines the standards for dental alloys in the United States.

• What storage guidelines should be followed for Argelite A?

  To maintain the integrity of Argelite A, storage should adhere to the manufacturer’s guidelines, which are not explicitly detailed here but typically involve protecting the alloy from moisture, contamination, and extreme temperatures. Proper storage ensures the alloy retains its mechanical properties and biocompatibility for reliable performance in dental restorations.

• Can Argelite A be used in all types of dental restorations?

  Argelite A is specifically engineered for ceramic veneering applications, where its high strength and biocompatibility are advantageous. While it is versatile for dental restorations requiring ceramic compatibility, its suitability for other types of restorations (e.g., crowns, bridges, or inlays) should be confirmed by consulting the manufacturer’s technical documentation or clinical guidelines, as performance may vary based on specific application requirements.