Vivasens
510(k) K030922
Vivasens is a Class II device made by Ivoclar Vivadent, Inc., cleared under FDA 510(k) K030922 on 17 Oct 2003, 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 | NumberK030922 | Date17 Oct 2003 | StatusActive |
Official records
- FDA 510(k) database K030922
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LBH
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3260
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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