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 IDK191475
510k NumberK191475
Device Name:Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Nobel Biocare AB BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg,  SE Se-411 17
ContactCharlemagne Chua
CorrespondentElena Cavallini
Nobel Biocare Services AG Balz Zimmermann-Strasse 7 Kloten Zurich,  CH 8302
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-04
Decision Date2019-08-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747167184 K191475 000
07332747167177 K191475 000
07332747167160 K191475 000
07332747167153 K191475 000

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