Aurolite 54+2

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

510(k) Number

K940435 ↗

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 primary use of the Aurolite 54+2?

  Aurolite 54+2 is a gold-based noble metal alloy specifically formulated for use in dental applications. It is classified as a dental device under regulation number 872.3060.

• Has this device received regulatory clearance?

  Yes, Aurolite 54+2 has received FDA 510(k) clearance. The device was cleared under submission number K940435, which determined it to be substantially equivalent to other devices on the market.

• Who is the manufacturer of this dental alloy?

  Aurolite 54+2 is manufactured by Argen Precious Metals, Inc., located in San Diego, California.