ARGEDENT 87

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

510(k) Number

K892662 ↗

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 ARGEDENT 87 used for in dental applications?

  ARGEDENT 87 is a gold-based noble metal alloy specifically designed for dental procedures. It is classified as a Class II medical device and intended for various dental applications where a high-quality noble metal alloy is required.

• How is ARGEDENT 87 supplied and what sizes are available?

  ARGEDENT 87 is supplied in various sizes to accommodate different dental procedures and requirements. The specific size options are not detailed in the available information, but the manufacturer offers multiple configurations to meet clinical needs.

• What is the regulatory status of ARGEDENT 87?

  ARGEDENT 87 has received FDA 510(k) clearance, which means it has been determined to be substantially equivalent to existing predicate devices. It is classified as a Class II medical device and regulated under product code EJT.

• Is ARGEDENT 87 a single-use device or can it be reused?

  The device data does not specify whether ARGEDENT 87 is designed for single-use or multiple reuse. This information would typically be found in the product's instructions for use, which are not included in the provided data.