The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Brilliant Componeer.
| Device ID | K191385 |
| 510k Number | K191385 |
| Device Name: | BRILLIANT COMPONEER |
| 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 | 2019-05-23 |
| Decision Date | 2019-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00660023179 | K191385 | 000 |
| J00660023165 | K191385 | 000 |
| J00660023164 | K191385 | 000 |
| J00660023163 | K191385 | 000 |
| J00660023162 | K191385 | 000 |
| J00660023161 | K191385 | 000 |
| J00660023160 | K191385 | 000 |
| J00660023159 | K191385 | 000 |
| J00660023158 | K191385 | 000 |
| J00660023157 | K191385 | 000 |
| J00660023182 | K191385 | 000 |
| J00660023183 | K191385 | 000 |
| J00660023178 | K191385 | 000 |
| J00660023177 | K191385 | 000 |
| J00660023169 | K191385 | 000 |
| J00660023168 | K191385 | 000 |
| J00660023215 | K191385 | 000 |
| J00660023201 | K191385 | 000 |
| J00660023187 | K191385 | 000 |
| J00660023186 | K191385 | 000 |
| J00660023185 | K191385 | 000 |
| J00660023155 | K191385 | 000 |
| J00660023153 | K191385 | 000 |
| J00660023152 | K191385 | 000 |
| J00660023137 | K191385 | 000 |
| J00660023136 | K191385 | 000 |
| J00660023135 | K191385 | 000 |
| J00660023134 | K191385 | 000 |
| J00660023133 | K191385 | 000 |
| J00660023132 | K191385 | 000 |
| J00660023131 | K191385 | 000 |
| J00660023130 | K191385 | 000 |
| J00660023129 | K191385 | 000 |
| J00660023138 | K191385 | 000 |
| J00660023139 | K191385 | 000 |
| J00660023151 | K191385 | 000 |
| J00660023149 | K191385 | 000 |
| J00660023148 | K191385 | 000 |
| J00660023145 | K191385 | 000 |
| J00660023144 | K191385 | 000 |
| J00660023143 | K191385 | 000 |
| J00660023142 | K191385 | 000 |
| J00660023141 | K191385 | 000 |
| J00660023140 | K191385 | 000 |
| J00660023128 | K191385 | 000 |
| J00660023193 | K191385 | 000 |
| J00660023166 | K191385 | 000 |
| J00660023156 | K191385 | 000 |
| J00660023154 | K191385 | 000 |
| J00660023150 | K191385 | 000 |
| J00660023214 | K191385 | 000 |
| J00660023213 | K191385 | 000 |
| J00660023212 | K191385 | 000 |
| J00660023211 | K191385 | 000 |
| J00660023210 | K191385 | 000 |
| J00660023167 | K191385 | 000 |
| J00660023170 | K191385 | 000 |
| J00660023192 | K191385 | 000 |
| J00660023184 | K191385 | 000 |
| J00660023181 | K191385 | 000 |
| J00660023176 | K191385 | 000 |
| J00660023175 | K191385 | 000 |
| J00660023174 | K191385 | 000 |
| J00660023173 | K191385 | 000 |
| J00660023172 | K191385 | 000 |
| J00660023171 | K191385 | 000 |
| J00660023209 | K191385 | 000 |
| J00660023207 | K191385 | 000 |
| J00660023206 | K191385 | 000 |
| J00660023124 | K191385 | 000 |
| J00660023123 | K191385 | 000 |
| J00660023122 | K191385 | 000 |
| J00660023196 | K191385 | 000 |
| J00660023195 | K191385 | 000 |
| J00660023191 | K191385 | 000 |
| J00660023190 | K191385 | 000 |
| J00660023189 | K191385 | 000 |
| J00660023188 | K191385 | 000 |
| J00660023125 | K191385 | 000 |
| J00660023126 | K191385 | 000 |
| J00660023204 | K191385 | 000 |
| J00660023203 | K191385 | 000 |
| J00660023200 | K191385 | 000 |
| J00660023198 | K191385 | 000 |
| J00660023197 | K191385 | 000 |
| J00660023194 | K191385 | 000 |
| J00660023147 | K191385 | 000 |
| J00660023146 | K191385 | 000 |
| J00660023127 | K191385 | 000 |
| J00660023180 | K191385 | 000 |