Dentabond Gold Alloy for Porcelain

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

510(k) Number

K903833 ↗

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 types of dental restorations is this gold alloy specifically designed for, and how does it differ from other alloys in this category?

  The Dentabond Gold Alloy for Porcelain is specifically designed for use in porcelain-fused-to-metal crowns and bridge restorations. It is a gold-based noble metal alloy, which means it contains precious metals like gold, providing superior biocompatibility and structural integrity for fixed prosthodontics. Unlike some other alloys that may contain less noble metals, this alloy is formulated to ensure long-term durability and compatibility with porcelain, making it ideal for cases where aesthetics and strength are critical.

• Is this alloy intended for single-use or can it be reused in multiple dental restorations?

  This alloy is not intended for single-use. It is supplied as a dental-grade material for professional use in dental laboratories and clinics, designed to be reused in the casting of multiple dental restorations. The regulatory data does not specify sterility requirements or limitations on reuse, indicating it is meant for repeated use in fabrication processes.

• What regulatory pathway was followed for this device’s approval, and what does that mean for its use in clinical settings?

  The Dentabond Gold Alloy for Porcelain received a Traditional 510(k) clearance (K903833) under FDA regulations, which means it was determined to be substantially equivalent to a predicate device already on the market. This pathway confirms its safety and effectiveness for its intended use in porcelain-fused-to-metal crowns and bridges. Clinically, this approval ensures the alloy meets established standards for biocompatibility and structural integrity in fixed prosthodontics.

• Are there any specific storage requirements mentioned for this alloy, and what should clinicians or labs consider when handling it?

  The regulatory data does not specify any particular storage conditions for the Dentabond Gold Alloy for Porcelain. However, as with any dental-grade material, it should be stored in a clean, dry environment away from direct sunlight, moisture, and contaminants to maintain its integrity. Proper handling and storage are essential to prevent oxidation or degradation, which could affect its performance in casting dental restorations.