Nobel Biocare Dental Implant Systems Portfolio - MR Conditional

Implant, Endosseous, Root-form

Nobel Biocare AG

The following data is part of a premarket notification filed by Nobel Biocare Ag with the FDA for Nobel Biocare Dental Implant Systems Portfolio - Mr Conditional.

Pre-market Notification Details

Device IDK212125
510k NumberK212125
Device Name:Nobel Biocare Dental Implant Systems Portfolio - MR Conditional
ClassificationImplant, Endosseous, Root-form
Applicant Nobel Biocare AG P.O. Box, 8058 Zurich - Airport Balsberg, Balz Zimmermann-str. 7,  CH 8302
ContactBernice Jim
CorrespondentBernice Jim
Nobel Biocare AG P.O. Box, 8058 Zurich - Airport Balsberg, Balz Zimmermann-str. 7,  CH 8302
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-07
Decision Date2021-09-24

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.