Omnichroma Flow Bulk
by Tokuyama Dental Corporation
510(k) K203598
Omnichroma Flow Bulk is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K203598 on 3 Feb 2021, 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 | NumberK203598 | Date3 Feb 2021 | StatusActive |
Official records
- FDA 510(k) database K203598
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- Withdrawn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 K203598
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 | |||
|---|---|---|---|---|
| OMNICHROMA FLOW BULK 10221 | 10221 | 04548190102211 | — | On the market |
| OMNICHROMA FLOW BULK 10225 | 10225 | 04548190102259 | — | On the market |
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