Aurecast GF

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K972319 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Palaurex 76KF

  Class II

  FDA 510(k) K972953 Active Cleared 5 Sep 1997

• Aurebond 51

  Class II

  FDA 510(k) K972952 Active Cleared 5 Sep 1997

• Aurecast 92

  Class II

  FDA 510(k) K972943 Active Cleared 16 Sep 1997

• Palceram 56

  Class II

  FDA 510(k) K972955 Active Cleared 5 Sep 1997

• Aurecast 74

  Class II

  FDA 510(k) K972941 Active Cleared 28 Aug 1997

• Aurecast 4

  Class II

  FDA 510(k) K972937 Active Cleared 25 Aug 1997

See all devices from Aurex Precious Metal Industries (Pty)Ltd →

• What types of dental restorations is the Aurecast GF alloy intended for, and how is it supplied?

  The Aurecast GF is a reusable gold-based noble metal alloy specifically designed for dental restorative procedures, including crowns, bridges, and inlays. It is supplied as a casting alloy, meaning it is melted and poured into molds to create precise dental restorations. Since it is reusable, it requires proper handling, sterilization, and recycling per dental practice standards.

• Is the Aurecast GF alloy single-use or reusable, and what does that mean for my practice?

  The Aurecast GF alloy is not single-use—it is a reusable dental alloy. This means it can be melted down, recast, and reused multiple times for creating new restorations. However, reuse requires adherence to strict sterilization and handling protocols to maintain biocompatibility and prevent contamination, as outlined in dental practice guidelines.

• What regulatory pathway does the Aurecast GF follow, and what does that mean for its use in the U.S.?

  The Aurecast GF is regulated under the FDA’s 510(k) clearance pathway, specifically under K972319, and classified as Class II with special controls (regulation 872.3060). This means it has been determined to be substantially equivalent to a predicate device and meets FDA requirements for safety and effectiveness in dental restorative applications. Its approval status ensures compliance with U.S. dental device regulations.

• How is the Aurecast GF alloy different from other dental casting alloys, and why might a clinician choose it?

  The Aurecast GF is a gold-based noble metal alloy, which distinguishes it from non-precious alloys by offering superior durability, biocompatibility, and corrosion resistance—key factors for long-term dental restorations like crowns or bridges. Clinicians may prefer it for patients requiring high-performance, long-lasting restorations where aesthetic and functional reliability are critical.

• Are there specific storage requirements for the Aurecast GF alloy, and how should it be handled?

  While the provided data does not specify exact storage conditions, as a reusable dental alloy, the Aurecast GF should be stored in a clean, dry environment to prevent oxidation or contamination. Proper labeling, secure packaging, and adherence to dental practice sterilization protocols (e.g., autoclaving or chemical sterilization) are essential before reuse to ensure safety and efficacy in casting procedures.