The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Brilliant Everglow Flow.
| Device ID | K190597 |
| 510k Number | K190597 |
| Device Name: | BRILLIANT EverGlow Flow |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Coltene/Whaledent AG Feldwiesenstrasse 20 Altstatten, CH 9450 |
| Contact | Wolfgang Dorner |
| Correspondent | Wolfgang Dorner Coltene/Whaledent AG Feldwiesenstrasse 20 Altstatten, CH 9450 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-07 |
| Decision Date | 2019-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00660019760 | K190597 | 000 |
| J0006600368240 | K190597 | 000 |
| J00660019751 | K190597 | 000 |
| J00660019752 | K190597 | 000 |
| J00660019753 | K190597 | 000 |
| J00660019754 | K190597 | 000 |
| J00660019755 | K190597 | 000 |
| J00660019756 | K190597 | 000 |
| J00660019757 | K190597 | 000 |
| J00660019758 | K190597 | 000 |
| J0006600332800 | K190597 | 000 |