Straumann TLX Novaloc And Cementable Abutments

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 Tlx Novaloc And Cementable Abutments.

Pre-market Notification Details

Device IDK203355
510k NumberK203355
Device Name:Straumann TLX Novaloc And Cementable Abutments
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Institut Straumann AG Peter Merian Weg 12 Basel,  CH Ch-4002
ContactLaure Kuhner Borsenberger
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 Received2020-11-16
Decision Date2021-02-12

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