Omnichroma Flow
by Tokuyama Dental Corporation
510(k) K193537
Omnichroma Flow is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K193537 on 19 Aug 2020, 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 | NumberK193537 | Date19 Aug 2020 | StatusActive |
Official records
- FDA 510(k) database K193537
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- Withdrawn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 K193537
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 10220 | 10220 | 04548190102204 | — | On the market |
| OMNICHROMA FLOW 10224 | 10224 | 04548190102242 | — | On the market |
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Other devices filed under FDA product code EBF (Material, Tooth Shade, Resin).
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- DiaFil Flow Economic Package A2 A2001-4102 by DiaDent Group International
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