Straumann CARES M-Series CAD/CAM System

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 Cares M-series Cad/cam System.

Pre-market Notification Details

Device IDK203456
510k NumberK203456
Device Name:Straumann CARES M-Series CAD/CAM System
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Institut Straumann AG Peter Merian-Weg 12 Basel,  CH Ch-4002
ContactGordon Dodds
CorrespondentJennifer M Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  ME  01810
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-06-23

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