The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Brilliant Everglow.
Device ID | K152927 |
510k Number | K152927 |
Device Name: | BRILLIANT EVERGLOW |
Classification | Material, Tooth Shade, Resin |
Applicant | COLTENE/WHALEDENT AG FELDWIESENTR. 20 Altstatten, CH 9450 |
Contact | Silke Wallaschek |
Correspondent | Silke Wallaschek COLTENE/WHALEDENT AG FELDWIESENTR. 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 | 2015-10-05 |
Decision Date | 2016-04-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
J00660024169 | K152927 | 000 |
J006600197240 | K152927 | 000 |
J006600197250 | K152927 | 000 |
J006600197280 | K152927 | 000 |
J006600197290 | K152927 | 000 |
J006600197350 | K152927 | 000 |
J006600197360 | K152927 | 000 |
J006600197370 | K152927 | 000 |
J006600219200 | K152927 | 000 |
J00660024160 | K152927 | 000 |
J00660024161 | K152927 | 000 |
J00660024162 | K152927 | 000 |
J00660024163 | K152927 | 000 |
J00660024166 | K152927 | 000 |
J00660024167 | K152927 | 000 |
J00660024168 | K152927 | 000 |
J00660019759 | K152927 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BRILLIANT EVERGLOW 79171038 4894038 Live/Registered |
Coltène/Whaledent AG 2015-06-25 |