Straumann TLX Implant System

Implant, Endosseous, Root-form

Institut Straumann AG

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

Pre-market Notification Details

Device IDK200586
510k NumberK200586
Device Name:Straumann TLX Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Institut Straumann AG Peter Merian Weg 12 Basel,  CH 4002
ContactRenate Reiss
CorrespondentJennifer M Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  MA  01810
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-06
Decision Date2020-08-20

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