Omnichroma Flow
Material, Tooth Shade, Resin
Tokuyama Dental Corporation
The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Omnichroma Flow.
Pre-market Notification Details
| Device ID | K193537 |
| 510k Number | K193537 |
| Device Name: | Omnichroma Flow |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo, JP 110-0016 |
| Contact | Keith A. Barritt |
| Correspondent | Keith A. Barritt Fish & Richardson P.C. 1000 Maine Avenue, S.W. Suite 1000 Washington, DC 20024 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-08-19 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190102204 | K193537 | 000 |
Trademark Results [Omnichroma Flow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNICHROMA FLOW 79275695 not registered Live/Pending |
TOKUYAMA CORPORATION 2019-09-17 |
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