BRILLIANT Crios
Material, Tooth Shade, Resin
Coltene/Whaledent AG
The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Brilliant Crios.
Pre-market Notification Details
| Device ID | K181500 |
| 510k Number | K181500 |
| Device Name: | BRILLIANT Crios |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Coltene/Whaledent AG Feldwiesenstrasse 20 Altstaetten, CH 9450 |
| Contact | Daniel Meier |
| Correspondent | Stuart R Goldman Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-07 |
| Decision Date | 2018-08-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00660020023 | K181500 | 000 |
| J00660024179 | K181500 | 000 |
| J00660020011 | K181500 | 000 |
| J00660020012 | K181500 | 000 |
| J00660020013 | K181500 | 000 |
| J00660020014 | K181500 | 000 |
| J00660020015 | K181500 | 000 |
| J00660020016 | K181500 | 000 |
| J00660020017 | K181500 | 000 |
| J00660020018 | K181500 | 000 |
| J00660020019 | K181500 | 000 |
| J00660020020 | K181500 | 000 |
| J00660020021 | K181500 | 000 |
| J00660020022 | K181500 | 000 |
| J00660024177 | K181500 | 000 |
Trademark Results [BRILLIANT Crios]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRILLIANT CRIOS 79192476 5225392 Live/Registered |
Coltène/Whaledent AG 2016-03-31 |
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