Straumann Variobase C

Abutment, Implant, Dental, Endosseous

Institut Straumann AG

The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Variobase C.

Pre-market Notification Details

Device IDK192742
510k NumberK192742
Device Name:Straumann Variobase C
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Institut Straumann AG Lochhamer Schlag 6 Grafelfing,  DE 82166
ContactGordon Dodds
CorrespondentJennifer M. Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  MA  01801
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2021-02-12

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