Bluephase 16I
510(k) K051782
Bluephase 16I is a Class II device made by Ivoclar Vivadent, Inc., cleared under FDA 510(k) K051782 on 20 Sep 2005, 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 | NumberK051782 | Date20 Sep 2005 | StatusActive |
Official records
- FDA 510(k) database K051782
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBZ
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6070
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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