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 IDK200810
510k NumberK200810
Device Name:IPS CaseDesigner
ClassificationSystem, Image Processing, Radiological
Applicant Nobel Biocare AB BOX 5190, SE-402 26, Vastra Hamngatan I Goteborg,  SE Se-411 17
ContactElena Cavallini
CorrespondentVladislavs Mihailovs
Nobel Biocare C/o Medicim NV Stationsstraat 102 Mechelen,  BE 2800
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-27
Decision Date2020-10-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747172065 K200810 000
07332747172065 K200810 000
07332747172058 K200810 000
07332747172065 K200810 000
07332747172058 K200810 000
07332747172065 K200810 000
07332747172058 K200810 000
07332747172065 K200810 000
07332747172058 K200810 000
07332747172065 K200810 000
07332747172058 K200810 000
07332747172065 K200810 000
07332747172058 K200810 000
07332747172065 K200810 000
07332747172058 K200810 000
07332747172065 K200810 000
07332747172058 K200810 000
07332747172058 K200810 000

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