Argelite 58P (Dental Alloy)

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

510(k) Number

K891320 ↗

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 Argelite 58P used for in dental applications?

  Argelite 58P is a dental alloy specifically designed for use as a ceramic veneering material. Its noble metal composition with 58% palladium provides excellent strength and biocompatibility, making it suitable for dental restorations.

• How is Argelite 58P supplied and what sizes are available?

  Argelite 58P is supplied as a dental material in various sizes to accommodate different dental applications. The manufacturer, Argen Precious Metals, Inc., offers multiple sizes to meet the specific needs of dental professionals.

• What is the regulatory status of Argelite 58P?

  Argelite 58P is regulated under FDA 510(k) clearance with product code EJT. It has been determined to be substantially equivalent to other predicate devices in its class, specifically for dental applications.

• Is Argelite 58P a single-use or reusable dental material?

  The device data does not specify whether Argelite 58P is intended for single-use or reuse. As a dental alloy, its usage would depend on the specific clinical application and standard dental practices regarding material reuse.