Straumann CARES Abutments CoCr

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 Abutments Cocr.

Pre-market Notification Details

Device IDK172798
510k NumberK172798
Device Name:Straumann CARES Abutments CoCr
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Institut Straumann AG Peter Merian Weg 12 Basel,  CH Ch-4002
ContactShokoufeh Khodabandeh
CorrespondentJennifer M. Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  MA  01801
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-18
Decision Date2018-01-03
Summary:summary

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