Argenco 75

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

510(k) Number

K903279 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K892814 Active Cleared 22 May 1989

• Surefire W

  Class II

  FDA 510(k) K940342 Active Cleared 4 Mar 1994

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  Class II

  FDA 510(k) K935973 Active Cleared 28 Jan 1994

• Argedent 62 Dental Alloy

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  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 the Argenco 75 alloy specifically designed for, and why is this material considered suitable for these applications?

  The Argenco 75 is designed for dental crowns, inlays, onlays, and other fixed prosthetics. It is a Type III gold-based noble metal alloy, which means it combines durability with biocompatibility—critical for long-term use inside the mouth. This alloy adheres to BS EN ISO 22674 standards, ensuring consistent mechanical and thermal properties that are essential for precision restorations in dental labs and offices.

• Is the Argenco 75 alloy sterile when supplied, and how should it be handled to maintain its integrity for use in dental restorations?

  The Argenco 75 is supplied in a non-sterile, reusable form. Since it is intended for laboratory or office use, it does not require sterilization before use. However, proper handling—such as keeping it clean and free from contamination—is essential to preserve its composition and performance for repeated use in casting dental restorations.

• What regulatory pathway was followed for the Argenco 75, and how does this affect its use in dental practices?

  The Argenco 75 received FDA 510(k) clearance (K903279) under a Traditional 510(k) review, with a decision of Substantially Equivalent (SESE) to a predicate device. This means it meets FDA standards for safety and effectiveness as a gold-based noble metal alloy for dental restorations. Clinicians and labs can rely on its compliance with BS EN ISO 22674, ensuring predictable mechanical properties for crowns, inlays, and onlays.

• How does the Argenco 75 differ from other dental alloys in terms of its composition and intended use?

  The Argenco 75 is specifically a Type III gold-based noble metal alloy, meaning it contains a higher proportion of gold and other noble metals compared to base-metal alloys. This composition provides superior biocompatibility and corrosion resistance, making it ideal for fixed prosthetics where longevity and patient comfort are priorities. Unlike some alloys that may require additional processing, this alloy is designed for straightforward use in dental labs and offices for casting restorations.