DenMat Bulk Fill Composite
510(k) K242097
DenMat Bulk Fill Composite is a Class II device made by Den-Mat Holdings, LLC, cleared under FDA 510(k) K242097 on 15 Oct 2024, 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 | NumberK242097 | Date15 Oct 2024 | StatusActive |
Official records
- FDA 510(k) database K242097
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- Withdrawn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 K242097
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 | |||
|---|---|---|---|---|
| EVANESCE 321523 | 321523 / 321523 | 03598833215236 | — | On the market |
| EVANESCE 321524 | 321524 / 321524 | 00359883325121 | — | On the market |
| EVANESCE 321525 | 321525 / 321525 | 03598833215250 | — | On the market |
| EVANESCE 973210 | 973210 / 973210 | 00359883973216 | — | On the market |
Similar devices
Other devices filed under FDA product code EBF (Material, Tooth Shade, Resin).
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