OMNICHROMA
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.
Pre-market Notification Details
| Device ID | K173275 |
| 510k Number | K173275 |
| Device Name: | OMNICHROMA |
| 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. 901 15th Street, Suite 700 Washington, DC 20005 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-12 |
| Decision Date | 2018-02-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190101320 | K173275 | 000 |
| 04548190101306 | K173275 | 000 |
| 04548190101269 | K173275 | 000 |
| 04548190101160 | K173275 | 000 |
Trademark Results [OMNICHROMA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNICHROMA 79259714 5946969 Live/Registered |
TOKUYAMA CORPORATION 2019-03-11 |
 OMNICHROMA 79212364 5477779 Live/Registered |
TOKUYAMA CORPORATION 2017-02-27 |
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