Argenco M-1 Type II Dental Gold Alloy

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

510(k) Number

K902900 ↗

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 M-1 Type II Dental Gold Alloy used for?

  The Argenco M-1 Type II Dental Gold Alloy is specifically designed for dental restorative applications where high biocompatibility and durability are essential. As a Type II gold alloy, it contains a higher gold content compared to other dental gold alloys, which enhances its resistance to corrosion and wear. This makes it suitable for creating long-lasting dental restorations such as crowns, inlays, or onlays where precision and stability are critical.

• Is the Argenco M-1 Type II Dental Gold Alloy reusable or single-use?

  The Argenco M-1 Type II Dental Gold Alloy is supplied as a reusable dental material. It is intended to be processed and reused multiple times in dental restorative procedures, following standard dental alloy handling and processing protocols. Unlike single-use materials, this alloy is designed for repeated use in clinical settings, provided it is handled and stored properly to maintain its integrity and performance.

• What regulatory approval does the Argenco M-1 Type II Dental Gold Alloy have?

  The Argenco M-1 Type II Dental Gold Alloy is cleared for commercial distribution under the FDA’s 510(k) process, with clearance number K902900. It falls under the FDA’s product code EJT and is classified as a Class II medical device with special controls. The product was cleared in 1990 and remains subject to regulatory requirements outlined in 21 CFR 872.3060. This approval ensures it meets the necessary safety and effectiveness standards for dental use.

• How should the Argenco M-1 Type II Dental Gold Alloy be stored?

  While specific sterility and handling instructions are not detailed in the regulatory data, the Argenco M-1 Type II Dental Gold Alloy should be stored in a clean, dry environment to prevent contamination or degradation. It is recommended to follow standard dental alloy storage practices, such as keeping it in a sealed container away from moisture, extreme temperatures, or direct sunlight. Proper storage ensures the alloy retains its composition and performance for reuse in dental procedures.

• What distinguishes the Argenco M-1 Type II Dental Gold Alloy from other dental gold alloys?

  The Argenco M-1 Type II Dental Gold Alloy is distinguished by its higher gold content, classifying it as a Type II gold alloy. This composition provides enhanced resistance to corrosion and wear compared to lower-grade dental gold alloys, making it ideal for applications requiring durability and longevity. Additionally, its FDA clearance and classification as a Class II medical device under product code EJT ensure it meets stringent regulatory standards for dental restorative materials.