nuance UNIVERSAL
510(k) K162967
nuance UNIVERSAL is a medical device (FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Den-Mat Holdings, LLC, cleared under FDA 510(k) K162967 on 24 Mar 2017, 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 | NumberK162967 | Date24 Mar 2017 | StatusActive |
Official records
- FDA 510(k) database K162967
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- Withdrawn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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