Argesol 830W

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

510(k) Number

K943089 ↗

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 Argisol 830W used for in dental restorations?

  The Argisol 830W is a gold-based noble metal alloy specifically designed as a dental solder. It is used in dental laboratories to join high noble and noble porcelain-fused-to-metal alloys during the fabrication of crowns, bridges, and other fixed prosthetics. This ensures a strong, biocompatible bond between metal frameworks and porcelain layers, resulting in long-lasting restorations.

• Is the Argisol 830W sterile or non-sterile, and how is it intended to be used?

  The Argisol 830W is supplied in a non-sterile state. It is intended for single-use per application, meaning each soldering process should use a fresh piece of the alloy. This ensures optimal performance and avoids cross-contamination between patients or procedures.

• What is the flow temperature of the Argisol 830W, and why does it matter?

  The Argisol 830W has a flow temperature of 1110°C, which is the temperature at which the alloy melts and flows to create a bond between metal and porcelain. This precise temperature is critical for achieving a strong, durable connection without damaging the porcelain or altering the metal framework’s integrity.

• How is the Argisol 830W supplied, and what should be considered during storage?

  The Argisol 830W is supplied as a soldering material, typically in wire or foil form, packaged for dental laboratory use. Since it is non-sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the alloy retains its properties and remains free from contamination until use.

• What regulatory clearance does the Argisol 830W hold, and how does this affect its use?

  The Argisol 830W holds an FDA 510(k) clearance under product code EJT, classified as a Class II medical device under regulation 872.3060. This clearance indicates that the device has been reviewed and deemed substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for dental soldering applications.