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
07332747202878	K200810	000
07332747199062	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
07332747202861	K200810	000