Transcend Bulk Fill Flowable Composite
510(k) K262228
Transcend Bulk Fill Flowable Composite is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K262228 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 | NumberK262228 | Date1 Jul 2026 | StatusActive |
Official records
- FDA 510(k) database K262228
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- Withdrawn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
Devices cleared under K262228
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Transcend 5876 | 5876 / 5876 | 00883205040411 | — | On the market |