Aurium 224 Gold-Based Noble Metal Alloy

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

Full name

Aurium 224

510(k) Number

K940111 ↗

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

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  FDA 510(k) K935973 Active Cleared 28 Jan 1994

• Argedent 62 Dental Alloy

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  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 Aurium 224 dental alloy used for?

  The Aurium 224 is a gold-based noble metal alloy designed specifically for dental restorative procedures. It is intended for use in creating durable crowns, bridges, and other fixed prosthetics where high strength, longevity, and biocompatibility are critical. Its formulation meets stringent dental standards to ensure reliable performance in the oral environment.

• Is the Aurium 224 alloy single-use or reusable?

  The Aurium 224 is supplied as a reusable dental material. It is not intended for single-use applications. Proper sterilization or cleaning procedures must be followed as per standard dental practice guidelines to maintain its integrity and safety for repeated use in restorative procedures.

• How is the Aurium 224 alloy regulated and approved?

  The Aurium 224 is regulated under FDA 510(k) clearance with the reference number K940111. It falls under FDA device classification 2 and is classified as a dental alloy for restorative use. The product is intended for clinical dental settings and must adhere to FDA regulation number 872.3060.

• What are the key characteristics that make Aurium 224 suitable for dental restorations?

  The Aurium 224 is engineered as a gold-based noble metal alloy to provide high durability and biocompatibility, which are essential for long-term success in dental restorations. Its formulation ensures resistance to corrosion and wear, making it ideal for crowns, bridges, and other fixed prosthetics where stability and patient comfort are priorities.

• Are there any special handling or storage requirements for the Aurium 224 alloy?

  While specific storage instructions are not detailed in the provided data, the Aurium 224 must be handled according to standard dental alloy processing protocols. Since it is reusable, it should be stored in a clean, dry environment to prevent contamination. Always follow manufacturer guidelines and local dental practice standards for proper storage and preparation.