V92
510(k) K911533
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911533 | Date29 Apr 1991 | 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- Withdrawn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, 25 Sep 2026
The V92 is a gold-based noble metal alloy device classified as a Class II medical device under the Dental specialty. It is identified by the device name Alloy, Gold-Based Noble Metal and was determined to be substantially equivalent through a traditional 510(k) clearance process.
The V92 was cleared by the FDA under 510(k) number K911533, with a decision date of April 29, 1991, and decision code SESE. It is manufactured by Metalor Dental USA Corp. and is associated with product code EJT and regulation number 872.3060.
Other devices from Metalor Dental USA Corp.
Questions
AI-generated answers, 25 Sep 2026
What is the V92 device used for?
The V92 is a gold-based noble metal alloy intended for dental applications, as indicated by its device name and classification under the Dental specialty in the FDA 510(k) clearance.
How was the V92 device cleared for market?
The V92 received clearance through a traditional 510(k) submission (K911533) based on a determination of substantial equivalence to a legally marketed predicate device, with a decision date of April 29, 1991.
What regulatory classification does the V92 have?
The V92 is classified as a Class II medical device under the Dental specialty, with product code EJT and regulation number 872.3060, as specified in its FDA 510(k) documentation.