SOLOCEM
Cement, Dental
COLTENE/WHALEDENT AG
The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Solocem.
Pre-market Notification Details
| Device ID | K121621 |
| 510k Number | K121621 |
| Device Name: | SOLOCEM |
| Classification | Cement, Dental |
| Applicant | COLTENE/WHALEDENT AG FELDWIESENSTRASSE 20 Altstatten, CH Ch-9450 |
| Contact | Silke Wallaschek |
| Correspondent | Silke Wallaschek COLTENE/WHALEDENT AG FELDWIESENSTRASSE 20 Altstatten, CH Ch-9450 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-01 |
| Decision Date | 2013-01-08 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00660019840 | K121621 | 000 |
| J006600199220 | K121621 | 000 |
| J006600139860 | K121621 | 000 |
| J006600140620 | K121621 | 000 |
| J006600140610 | K121621 | 000 |
| J006600139900 | K121621 | 000 |
Trademark Results [SOLOCEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLOCEM 79106529 4159768 Live/Registered |
Coltène/Whaledent AG 2011-09-30 |
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