Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA

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 Blx Temporary Abutment, Vita Cad-temp, Pmma.

Pre-market Notification Details

Device IDK220751
510k NumberK220751
Device Name:Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Institut Straumann AG Peter Merian Weg 12 Basel,  CH CH-4002
ContactViviana Horhoiu
CorrespondentJennifer M Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  MA  01810
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-15
Decision Date2022-06-02


Device IdentifiersubmissionNumberSupplement
07630031759276 K220751 000
07630031759269 K220751 000
07630031759252 K220751 000

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