Esthetic Abutments Nobel Biocare N1

Abutment, Implant, Dental, Endosseous

Nobel Biocare Services AG

The following data is part of a premarket notification filed by Nobel Biocare Services Ag with the FDA for Esthetic Abutments Nobel Biocare N1.

Pre-market Notification Details

Device IDK220339
510k NumberK220339
Device Name:Esthetic Abutments Nobel Biocare N1
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Nobel Biocare Services AG Balz Zimmermann-Str. 7 Kloten,  CH 8302
ContactBernice Jim
CorrespondentBernice Jim
Nobel Biocare Services AG Balz Zimmermann-Str. 7 Kloten,  CH 8302
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-07
Decision Date2022-09-16

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