Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Nobel Biocare AB

The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobel Biocare N1 Pureset Tray, Nobel Biocare N1 Pureset Plate, Prosthetic Pureset Tray, Prosthetic Pureset Plate.

Pre-market Notification Details

• Device ID: K191475
• 510k Number: K191475
• Device Name: Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: Nobel Biocare AB BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg, SE Se-411 17
• Contact: Charlemagne Chua
• Correspondent: Elena Cavallini; Nobel Biocare Services AG Balz Zimmermann-Strasse 7 Kloten Zurich, CH 8302
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-04
• Decision Date: 2019-08-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07332747167184	K191475	000
07332747167177	K191475	000
07332747167160	K191475	000
07332747167153	K191475	000