Argenco 68M

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

510(k) Number

K954361 ↗

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 intended use of the Argenco 68M?

  The Argenco 68M is a gold-based noble metal alloy specifically designed for dental restorative applications. It is classified as a dental device under 21 CFR 872.3060.

• Has the Argenco 68M received regulatory clearance?

  Yes, this device has received FDA 510(k) clearance under the number K954361. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

• Who is the manufacturer of the Argenco 68M?

  The Argenco 68M is manufactured by Argen Precious Metals, Inc., located in San Diego, California. The company is the applicant of record for the FDA 510(k) clearance.