M-1 Gold Base Dental Alloy

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

510(k) Number

K891521 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• M-65 Gold Base Dental Alloy

  Class II

  FDA 510(k) K891528 Active Cleared 12 Apr 1989

• M-4 Gold Base Dental Alloy

  Class II

  FDA 510(k) K891522 Active Cleared 12 Apr 1989

• C-52 Gold Base Dental Alloy

  Class II

  FDA 510(k) K891515 Active Cleared 7 Apr 1989

• M-75 Gold Base Dental Alloy

  Class II

  FDA 510(k) K891534 Active Cleared 12 Apr 1989

• M-20 Gold Base Dental Alloy

  Class II

  FDA 510(k) K891523 Active Cleared 12 Apr 1989

• C-5 Palladium Base Dental Alloy

  Class II

  FDA 510(k) K891514 Active Cleared 12 Apr 1989

See all devices from Macdonald Metals and Ceramics →

• What types of dental restorations is the M-1 Gold Base Dental Alloy specifically designed for?

  The M-1 Gold Base Dental Alloy is designed for use in dental restorative procedures, including crowns, bridges, and inlays. Its gold-based noble metal composition provides durability and biocompatibility, making it suitable for long-term restorations where strength and patient tolerance are critical.

• Is the M-1 Gold Base Dental Alloy reusable or single-use, and how should it be handled?

  The M-1 Gold Base Dental Alloy is supplied as a reusable dental material. Since it is intended for repeated use in clinical settings, proper sterilization protocols must be followed between applications to maintain safety and performance standards. Always adhere to manufacturer guidelines for cleaning and sterilization.

• What regulatory pathway was followed for FDA clearance of this dental alloy?

  The M-1 Gold Base Dental Alloy received FDA clearance through a 510(k) submission (K891521), classified as Class II under regulation 872.3060. The submission was reviewed by the Dental (DE) Advisory Committee and determined to be substantially equivalent to a predicate device, ensuring compliance with dental material performance and safety standards.

• How is the M-1 Gold Base Dental Alloy categorized in terms of its metal composition?

  The M-1 Gold Base Dental Alloy is classified as a gold-based noble metal alloy, meaning it contains gold as its primary component alongside other noble metals. This classification ensures high biocompatibility and corrosion resistance, making it ideal for dental applications requiring long-term stability.