Argesol PNP

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

510(k) Number

K943209 ↗

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 Argesol PNP specifically used for in dental procedures?

  The Argesol PNP is a gold-based noble metal alloy designed exclusively for dental soldering. It is intended to join metal components in porcelain-fused-to-metal restorations, ensuring a secure bond between parts like crowns, bridges, or other dental frameworks.

• Is the Argesol PNP meant for reuse or single-use in a clinical setting?

  The Argesol PNP is explicitly labeled for single-use in clinical settings. Since it is a soldering material, proper handling and sterility protocols must be followed to prevent contamination, as reuse is not recommended.

• How is the sterility of the Argesol PNP maintained during use?

  The Argesol PNP is supplied as a sterile dental soldering alloy, requiring careful handling to preserve its sterility. Since it is intended for single-use, it should only be opened and used in a controlled clinical environment to avoid compromising its sterile state.

• What regulatory pathway did the Argesol PNP follow to gain market authorization?

  The Argesol PNP was cleared through the FDA’s 510(k) process, specifically under the Traditional pathway, with clearance number K943209 dated August 1, 1994. It is classified under 21 CFR 872.3060 and is categorized as a dental soldering alloy.