P.004 ABUTMENTS

Abutment, Implant, Dental, Endosseous

STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG)

The following data is part of a premarket notification filed by Straumann Usa (on Behalf Of Institut Straumann Ag) with the FDA for P.004 Abutments.

Pre-market Notification Details

Device IDK071919
510k NumberK071919
Device Name:P.004 ABUTMENTS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) 60 MINUTEMAN ROAD Andover,  MA  01810
ContactPaige Sweeney
CorrespondentPaige Sweeney
STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) 60 MINUTEMAN ROAD Andover,  MA  01810
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-12
Decision Date2007-09-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630031708915 K071919 000
07630031708908 K071919 000
07630031708144 K071919 000
07630031708137 K071919 000

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