C-87 Gold Base Dental Alloy

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

510(k) Number

K891520 ↗

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

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• What is the C-87 Gold Base Dental Alloy used for?

  The C-87 Gold Base Dental Alloy is a gold-based noble metal alloy specifically designed for dental casting applications. It is intended for use in various dental procedures where a high-quality metal alloy is required.

• What is the regulatory status of the C-87 Gold Base Dental Alloy?

  The C-87 Gold Base Dental Alloy has FDA 510(k) clearance with number K891520. It is classified as a Class II medical device and is regulated under product code EJT and regulation number 872.3060.

• Is the C-87 Gold Base Dental Alloy supplied sterile?

  The device data does not provide information regarding the sterility status of the C-87 Gold Base Dental Alloy. For specific details about sterility, it would be necessary to contact the manufacturer directly.

• Is the C-87 Gold Base Dental Alloy single-use or reusable?

  The device data does not specify whether the C-87 Gold Base Dental Alloy is intended for single-use or reuse. This information would need to be obtained from the manufacturer or product documentation.