M-65 Gold Base Dental Alloy

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

510(k) Number

K891528 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• 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

• C-86 Gold Base Dental Alloy

  Class II

  FDA 510(k) K891519 Active Cleared 12 Apr 1989

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• What is the M-65 Gold Base Dental Alloy used for?

  The M-65 Gold Base Dental Alloy is designed specifically for dental restorations, serving as a durable and biocompatible substrate for crowns, inlays, onlays, and other fixed prosthetics. Its composition of gold and other metals provides mechanical strength, corrosion resistance, and aesthetic properties suitable for long-term dental applications.

• How is the M-65 Gold Base Dental Alloy supplied, and is it intended for reuse?

  This alloy is supplied in a form intended for dental fabrication and is explicitly designated for single-use in restorative procedures. Unlike some reusable materials, it is not designed to be sterilized or reused, ensuring patient safety and compliance with dental best practices.

• Is the M-65 Gold Base Dental Alloy sterile, and what storage guidelines apply?

  The M-65 Gold Base Dental Alloy is not described as sterile in its packaging or specifications. Storage should follow standard dental alloy protocols, adhering to manufacturer guidelines for dental materials. This typically includes keeping it in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity.

• What regulatory pathway does the M-65 Gold Base Dental Alloy follow?

  The M-65 Gold Base Dental Alloy is regulated under the FDA 510(k) clearance process as a Class II device (product code EJT, regulation 872.3060). It was granted substantial equivalence (SESE) via a traditional review in 1989, meaning it was deemed comparable to a legally marketed predicate device. This classification ensures it meets established safety and effectiveness standards for dental materials.