Straumann TLX Variobase C

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 Variobase C.

Pre-market Notification Details

Device IDK220878
510k NumberK220878
Device Name:Straumann TLX Variobase C
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Institut Straumann AG Peter Merian Weg 12 Basel,  CH CH-4002
ContactGordon Dodds
CorrespondentJennifer M. Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  MA  01810
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-25
Decision Date2022-06-16

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