Versaetch
510(k) K973257
Versaetch is a medical device (FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Centrix, Inc., cleared under FDA 510(k) K973257 on 17 Nov 1997, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973257 | Date17 Nov 1997 | StatusActive |
Official records
- FDA 510(k) database K973257
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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