Argenco 46 Type III Dental Gold Alloy

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

510(k) Number

K893444 ↗

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 Argenco 46 Type III Dental Gold Alloy used for?

  The Argenco 46 Type III Dental Gold Alloy is specifically designed for dental restorative applications, particularly for fabricating crowns and bridges. Its noble metal composition ensures biocompatibility and durability, making it ideal for long-term dental prosthetics where strength and aesthetic integration with natural teeth are critical.

• How is the Argenco 46 Type III Dental Gold Alloy supplied, and is it intended for single-use?

  This alloy is supplied in a form suitable for dental laboratory use, meaning it is intended to be processed by dental technicians to create restorations. According to its regulatory classification, it is designed for single-use in dental restorations, meaning each batch or unit is meant to be utilized once in a specific restoration before disposal or reprocessing.

• Is the Argenco 46 Type III Dental Gold Alloy sterile, and if so, how is sterility maintained?

  The provided data does not explicitly state whether the alloy is sterile as shipped. However, since it is intended for dental laboratory use—where sterility is typically achieved through separate sterilization protocols (e.g., autoclaving or chemical sterilization)—the alloy itself is likely supplied in a non-sterile form. Clinicians or lab technicians must follow appropriate sterilization procedures before use in patient care.

• What regulatory approval does the Argenco 46 Type III Dental Gold Alloy hold, and how does it classify under FDA guidelines?

  The Argenco 46 Type III Dental Gold Alloy has received FDA 510(k) clearance under the classification of Class II medical devices (EJT). This clearance indicates the device is deemed substantially equivalent to a legally marketed predicate device and is regulated under 21 CFR 872.3060, which governs dental alloys. The approval process involved a traditional 510(k) submission reviewed by the FDA’s Dental Advisory Committee.

• Are there different sizes or models of the Argenco 46 Type III Dental Gold Alloy, and how should it be stored?

  The provided specifications do not detail specific sizes or models beyond its classification as a Type III dental gold alloy, which typically refers to a standardized composition rather than discrete sizing. For storage, noble metal alloys like this should be kept in a cool, dry environment to prevent oxidation or contamination. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these factors can degrade the alloy’s integrity before use in restorative procedures.