Argicraft 1 Palladium Silver Alloy for Porcelain

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

510(k) Number

K903831 ↗

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 this alloy specifically designed for, and how does it integrate with ceramic materials?

  Argicraft 1 Palladium Silver Alloy is specifically formulated for use in porcelain-fused-to-metal crowns and bridge restorations. Its composition—primarily palladium, silver, and gold-based metals—provides the structural strength needed to support ceramic layers while ensuring aesthetic compatibility. The alloy’s design allows it to bond seamlessly with porcelain, enabling natural-looking and durable restorations.

• Is this alloy intended for reuse in multiple procedures, or is it meant for single-use only?

  Argicraft 1 Palladium Silver Alloy is explicitly intended for single-use in restorative dental procedures. The manufacturer’s description emphasizes its role as a casting material for one-time fabrication of porcelain-fused-to-metal restorations, making it unsuitable for reprocessing or reuse.

• How is this alloy regulated by the FDA, and what classification does it fall under?

  This alloy is classified under FDA product code EJT and falls into Class II with Special Controls for dental applications, regulated under 21 CFR 872.3060. It received a Traditional 510(k) clearance with a *Substantially Equivalent* decision in 1990 (K903831), confirming its compliance with dental device regulations. The clearance was reviewed by the Dental Advisory Committee (DE).

• What form does this alloy come in, and are there any specific handling or storage requirements mentioned?

  While the exact packaging isn’t detailed, Argicraft 1 is supplied as a dental casting material, typically in ingot or preformed shapes for use in casting procedures. As a single-use alloy, it should be stored in a dry, clean environment to prevent contamination. Since it’s not sterilized (as it’s non-reusable), proper inventory control and handling per dental protocols are recommended to ensure sterility of the final restoration.