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 | K161634 |
| 510k Number | K161634 |
| Device Name: | IPS CaseDesigner |
| Classification | System, Image Processing, Radiological |
| Applicant | NOBEL BIOCARE AB VASTRA HAMNGATAN 1 Goteborg, SE Se-411 17 |
| Contact | Charlemagne Chua |
| Correspondent | Charlemagne Chua NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-14 |
| Decision Date | 2016-11-10 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747157673 | K161634 | 000 |
| 07332747157666 | K161634 | 000 |
| 07332747126976 | K161634 | 000 |
| 07332747126969 | K161634 | 000 |
| 07332747125009 | K161634 | 000 |
| 07332747124996 | K161634 | 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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