Argiplus Alloy

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

Full name

Argiplus

510(k) Number

K910467 ↗

FDA Product Code

EJS

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 types of dental restorations can the Argiplus Alloy be used to fabricate, and where is it typically employed?

  The Argiplus Alloy is specifically designed for creating cast or porcelain-fused-to-metal dental crowns and bridges. Due to its composition of precious metals like gold, palladium, platinum, or silver, it provides the structural integrity and biocompatibility needed for long-term restorations. It is intended for use in dental laboratories and clinical settings where these restorations are fabricated, ensuring durability and compatibility with oral tissues.

• Is the Argiplus Alloy single-use or reusable, and what considerations should be taken for its handling?

  The Argiplus Alloy is not single-use—it is reusable and meant for repeated use in dental fabrication processes. Since it is a reusable dental alloy, proper handling, storage, and recycling in accordance with dental industry standards are essential to maintain its quality and prevent contamination. This ensures it remains safe and effective for subsequent restorative applications.

• How is the regulatory status of the Argiplus Alloy determined, and what classification does it fall under?

  The Argiplus Alloy is regulated under the FDA 510(k) clearance process, with the specific clearance number K910467. It is classified as a Class II medical device under regulation number 872.3060, meaning it has undergone evaluation to ensure its safety and effectiveness for its intended use in dental restorations. The clearance was granted in 1991 and is based on a determination of substantial equivalence to a predicate device.

• What are the key metal components of the Argiplus Alloy, and why are they important for dental restorations?

  The Argiplus Alloy is composed primarily of precious metals, including gold, palladium, platinum, or silver. These metals are critical because they provide structural integrity to the restoration while ensuring biocompatibility, reducing the risk of adverse reactions in the patient’s mouth. This composition is particularly valuable for crowns and bridges, where longevity and patient tolerance are paramount.