Straumann CI RD Ceramic Healing Caps

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 Ci Rd Ceramic Healing Caps.

Pre-market Notification Details

Device IDK190654
510k NumberK190654
Device Name:Straumann CI RD Ceramic Healing Caps
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Institut Straumann AG Peter Merian-Weg 12 Basel,  CH Ch-4002
ContactPierre-yves Calinon
CorrespondentJennifer M. Jackson
StraumannUSA, LLC 60 Minuteman Road Andover,  MA  01810
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-14
Decision Date2019-06-28

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