Straumann Cerabone

Bone Grafting Material, Animal Source

Institut Straumann AG

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

Pre-market Notification Details

Device IDK173594
510k NumberK173594
Device Name:Straumann Cerabone
ClassificationBone Grafting Material, Animal Source
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 CodeNPM  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-21
Decision Date2018-10-19
Summary:summary

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