Straumann RidgeFit Implants

Implant, Endosseous, Root-form

Institut Straumann AG

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

Pre-market Notification Details

Device IDK211052
510k NumberK211052
Device Name:Straumann RidgeFit Implants
ClassificationImplant, Endosseous, Root-form
Applicant Institut Straumann AG Peter Merian Weg 12 Basel,  CH Ch-4002
ContactViviana Horhoiu
CorrespondentJennifer M. Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  MA  01810
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-09
Decision Date2021-07-08

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