Straumann BoneCeramic

Bone Grafting Material, Synthetic

Institut Straumann AG

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

Pre-market Notification Details

Device IDK201051
510k NumberK201051
Device Name:Straumann BoneCeramic
ClassificationBone Grafting Material, Synthetic
Applicant Institut Straumann AG Peter Merian-Weg 12 Basel,  CH Ch-4002
ContactChristelle Gerspach-gasser
CorrespondentJennifer M. Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  MA  01801
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-21
Decision Date2020-09-24

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