In-Ovation C
510(k) K060837
In-Ovation C is a medical device (FDA Class II; FDA product code NJM, Bracket, Ceramic, Orthodontic) made by Dentsply International, cleared under FDA 510(k) K060837 on 10 Apr 2006, 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 | NumberK060837 | Date10 Apr 2006 | StatusActive |
Official records
- FDA 510(k) database K060837
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NJM
- Device class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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