The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Fill-up!.
| Device ID | K150218 |
| 510k Number | K150218 |
| Device Name: | Fill-Up! |
| Classification | Material, Tooth Shade, Resin |
| Applicant | COLTENE/WHALEDENT AG FELDWIESENSTRASSE 20 Altstatten, CH 9450 |
| Contact | Silke Wallaschek |
| Correspondent | Silke Wallaschek 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 | 2015-01-30 |
| Decision Date | 2015-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J006600199200 | K150218 | 000 |
| J006600193550 | K150218 | 000 |
| J006600193420 | K150218 | 000 |
| J006600199730 | K150218 | 000 |
| J006600193410 | K150218 | 000 |