Argistar 45 Gold Alloy for Porcelain

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

510(k) Number

K903819 ↗

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 is the Argistar 45 Gold Alloy for Porcelain used for?

  The Argistar 45 Gold Alloy for Porcelain is specifically designed for fabricating porcelain-fused-to-metal crowns and bridges in fixed prosthodontics. It combines gold and other noble metals to provide both structural stability and biocompatibility, ensuring durable and safe restorations for patients.

• Is the Argistar 45 Gold Alloy for Porcelain reusable or single-use?

  This alloy is intended for reuse in dental laboratories and clinical settings. It is not a single-use material but must be handled and stored according to standard dental material protocols to maintain sterility and integrity for repeated use in porcelain-fused-to-metal restorations.

• How should the Argistar 45 Gold Alloy for Porcelain be stored?

  The alloy should be stored following standard dental material protocols to ensure proper containment and sterility. This includes keeping it in a clean, dry environment, away from contaminants, and adhering to manufacturer guidelines to preserve its quality and performance for reuse in dental restorations.

• What regulatory pathway does the Argistar 45 Gold Alloy for Porcelain follow?

  The Argistar 45 Gold Alloy for Porcelain is regulated under the FDA 510(k) clearance process, specifically with clearance number K903819. It is classified as a Class II device under the product code EJT and is intended for use as a gold-based noble metal alloy in dental restorative applications.

• Is sterility maintained with reuse of the Argistar 45 Gold Alloy for Porcelain?

  While the alloy itself is reusable, sterility must be carefully managed through proper cleaning, sterilization, and storage protocols between uses. Dental professionals should follow established guidelines to ensure the alloy remains free from contamination and suitable for repeated use in porcelain-fused-to-metal restorations.