DuoCem
Cement, Dental
COLTENE/WHALEDENT AG
The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Duocem.
Pre-market Notification Details
| Device ID | K160800 |
| 510k Number | K160800 |
| Device Name: | DuoCem |
| Classification | Cement, Dental |
| Applicant | COLTENE/WHALEDENT AG FELDWIESENSTR. 20 Altstatten, CH 9450 |
| Contact | Silke Wallaschek |
| Correspondent | Silke Wallaschek COLTENE/WHALEDENT AG FELDWIESENSTR. 20 Altstatten, 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 | 2016-03-23 |
| Decision Date | 2016-11-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J006600195640 | K160800 | 000 |
| J006600195630 | K160800 | 000 |
| J006600143910 | K160800 | 000 |
| J006600143810 | K160800 | 000 |
Trademark Results [DuoCem]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUOCEM 79116331 4322685 Live/Registered |
Coltène/Whaledent AG 2012-07-24 |
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