Type III Dental Gold Alloy for Crown & Bridge App.

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

510(k) Number

K905761 ↗

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 this gold alloy be used for, and how is it supplied to dental labs?

  This Type III Dental Gold Alloy is specifically designed for fabricating cast or porcelain-fused-to-metal crowns and bridges, providing a durable and biocompatible solution for dental prosthetics. It is supplied in powder form, intended exclusively for single-use in casting procedures within dental laboratories. The powder form allows for precise mixing and casting, ensuring consistent results for restorative work.

• Is this alloy reusable, or is it meant for one-time use in a single casting?

  The alloy is intended for single-use only in casting procedures. Since it is supplied in powder form for laboratory use, it is not designed to be reused or reprocessed after a single casting. This ensures optimal performance and avoids potential contamination or degradation of material properties.

• Does this product come in multiple sizes or models, or is it a single formulation?

  The provided data does not specify distinct sizes or models for this alloy, as it is classified under a general Type III Dental Gold Alloy designation for crown and bridge applications. However, the registration numbers and product codes (e.g., EJT) suggest it may be available in various formulations or batches, though no granular details on variations (e.g., karat purity, hardness, or melting range) are provided. Laboratories would rely on the manufacturer’s documentation for exact specifications.

• How should this alloy be stored, and are there any special handling requirements?

  While the data does not explicitly detail storage conditions, dental alloys like this typically require dry, sealed packaging to prevent moisture absorption or contamination, which could affect casting quality. It should be stored in a cool, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s instructions for optimal shelf life and performance, as improper storage could compromise the alloy’s integrity before use.

• What regulatory pathway was followed for this device’s approval, and how does that affect its use?

  This alloy was cleared through the FDA’s 510(k) process (K905761), specifically under the Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. It is classified as a Class II medical device (regulation number 872.3060), meaning it undergoes premarket review to ensure safety and effectiveness for its intended use in dental restorations. Clinicians and labs can rely on this clearance to confirm its compliance with FDA standards for dental alloys, though they should still adhere to the manufacturer’s instructions for proper handling and application.