Argelite 76SF+ Dental Alloy

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

510(k) Number

K892910 ↗

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 can the Argelite 76SF+ Dental Alloy be used to fabricate, and how is it typically processed in a dental lab or clinic?

  The Argelite 76SF+ Dental Alloy is specifically designed for creating cast or porcelain-fused-to-metal crowns and bridges. It is processed by melting and casting the alloy into the desired prosthetic shape in dental laboratories or clinical settings. This gold-based noble metal alloy ensures durability and biocompatibility for long-term use in prosthetic dental work.

• Is the Argelite 76SF+ Dental Alloy intended for single-use or reusable applications, and how does this impact its handling in a dental practice?

  The Argelite 76SF+ Dental Alloy is explicitly described as a reusable material, meaning it is not designed for single-use. This classification means it must be properly stored, handled, and processed in compliance with dental laboratory protocols to maintain its integrity for repeated casting applications. Reusability also implies it should be cleaned and prepared according to manufacturer guidelines between uses.

• What regulatory pathway was followed for the FDA clearance of the Argelite 76SF+ Dental Alloy, and what does this mean for its use in dental practices?

  The Argelite 76SF+ Dental Alloy received FDA clearance through a 510(k) submission, specifically under the traditional clearance type, and was reviewed by the Dental (DE) Advisory Committee. This means the device was deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and performance standards for dental applications. Clinicians and labs can rely on this clearance as confirmation of its regulatory compliance for use in cast or porcelain-fused-to-metal crown and bridge restorations.

• How is the Argelite 76SF+ Dental Alloy categorized under FDA regulations, and what does this classification imply for its intended use?

  The Argelite 76SF+ Dental Alloy is classified under FDA regulation number 872.3060, which pertains to gold-based noble metal alloys used in dental applications. This classification confirms its intended use for dental laboratories and clinical settings where it is melted and cast into crowns, bridges, or porcelain-fused-to-metal restorations. The classification ensures it adheres to dental-specific regulatory standards for biocompatibility and performance.