DENTCA Tru Flexible
by Dentca, Inc.
510(k) K261474
DENTCA Tru Flexible is a Class II device made by Dentca, Inc., cleared under FDA 510(k) K261474 on 1 Jul 2026, 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 | NumberK261474 | Date1 Jul 2026 | StatusActive |
Official records
- FDA 510(k) database K261474
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBI
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent