P.004 NC ANATOMIC 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 P.004 Nc Anatomic Abutments.

Pre-market Notification Details

Device IDK071357
510k NumberK071357
Device Name:P.004 NC ANATOMIC ABUTMENTS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover,  MA  01810
ContactPaige Sweeney
CorrespondentPaige Sweeney
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 Received2007-05-15
Decision Date2007-09-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630031707871 K071357 000
07630031707864 K071357 000
07630031707857 K071357 000
07630031707840 K071357 000

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