IPS CaseDesigner
System, Image Processing, Radiological
Nobel Biocare AB
The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Ips Casedesigner.
Pre-market Notification Details
| Device ID | K200810 |
| 510k Number | K200810 |
| Device Name: | IPS CaseDesigner |
| Classification | System, Image Processing, Radiological |
| Applicant | Nobel Biocare AB BOX 5190, SE-402 26, Vastra Hamngatan I Goteborg, SE Se-411 17 |
| Contact | Elena Cavallini |
| Correspondent | Vladislavs Mihailovs Nobel Biocare C/o Medicim NV Stationsstraat 102 Mechelen, BE 2800 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-27 |
| Decision Date | 2020-10-08 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747172065 | K200810 | 000 |
| 07332747199079 | K200810 | 000 |
| 07332747197518 | K200810 | 000 |
| 07332747197525 | K200810 | 000 |
| 07332747185829 | K200810 | 000 |
| 07332747185836 | K200810 | 000 |
| 07332747181913 | K200810 | 000 |
| 07332747181920 | K200810 | 000 |
| 07332747178241 | K200810 | 000 |
| 07332747178258 | K200810 | 000 |
| 07332747172058 | K200810 | 000 |
| 07332747199062 | K200810 | 000 |
Trademark Results [IPS CaseDesigner]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IPS CASEDESIGNER 86966331 not registered Dead/Abandoned |
KLS-Martin, L.P. 2016-04-06 |
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