C-86 Gold Base Dental Alloy
by Macdonald Metals and Ceramics
510(k) K891519
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK891519 | Date12 Apr 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EJT
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3060
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The C-86 Gold Base Dental Alloy is a noble metal alloy composed primarily of gold, palladium, platinum, or silver. It is classified as a gold-based noble metal alloy intended for use in dental applications.
This device is regulated under FDA 510(k) clearance K891519. It is categorized as a class 2 medical device under regulation number 872.3060.
Other devices from Macdonald Metals and Ceramics
Questions
AI-generated answers, 27 Sep 2026
What is the C-86 Gold Base Dental Alloy used for?
This product is a noble metal alloy designed specifically for use in dental applications. It is formulated with a composition of gold, palladium, platinum, or silver to meet the requirements of dental restorative procedures.
What is the regulatory status of this dental alloy?
The C-86 Gold Base Dental Alloy is a class 2 medical device regulated under FDA 510(k) clearance number K891519. It is classified under regulation number 872.3060.
Who is the manufacturer of this dental alloy?
The C-86 Gold Base Dental Alloy is manufactured by Macdonald Metals and Ceramics, located in Santa Fe Springs, California.