Argedent 45

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

510(k) Number

K892814 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• 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

• Argesol R

  Class II

  FDA 510(k) K943088 Active Cleared 22 Jul 1994

See all devices from Argen Precious Metals, Inc. →

• What is the primary use of Argedent 45?

  Argedent 45 is a gold-based noble metal alloy specifically intended for use in dental applications. It is classified under regulation number 872.3060 as a dental alloy.

• Who is the manufacturer of this dental alloy?

  This device is manufactured by Argen Precious Metals, Inc., located in San Diego, California.

• Has this device received regulatory clearance?

  Yes, Argedent 45 has received FDA 510(k) clearance under K892814. The submission was processed as a traditional 510(k) and was determined to be substantially equivalent to existing devices.