Omnichroma Flow Bulk 10221
by Tokuyama Dental Corporation
Omnichroma Flow Bulk 10221 is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K203598 on 3 Feb 2021 and listed in FDA GUDID since 15 Mar 2021 (UDI-DI 04548190102211), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04548190102211 | Date15 Mar 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203598 | Date3 Feb 2021 | StatusActive |
Official records
- AccessGUDID record 04548190102211
- FDA 510(k) database K203598
Across registries
- FDA 510(k) K203598 decided 3 Feb 2021 Active
- FDA GUDID UDI-DI 04548190102211 listed 15 Mar 2021 Listed
Timeline
- Cleared FDA 510(k) K203598
- Listed FDA GUDID 04548190102211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Omnichroma Flow Bulk
- Generic name
- Dental composite resin
- Model / reference
- 10221
- Primary DI / UDI-DI
- 04548190102211
- 510(k) Number
- FDA product code
- EBF
- GMDN term
- Dental composite resin
- Device class
- Class II
- Regulation number
- 872.3690
- GUDID distribution status
- In Commercial Distribution
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