Straumann RN Gold Abutment For Bridge

Abutment, Implant, Dental, Endosseous

STRAUMANN USA, LLC

The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann Rn Gold Abutment For Bridge.

Pre-market Notification Details

Device IDK151590
510k NumberK151590
Device Name:Straumann RN Gold Abutment For Bridge
ClassificationAbutment, Implant, Dental, Endosseous
Applicant STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover,  MA  01810
ContactChristopher Klaczyk
CorrespondentChristopher Klaczyk
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 Received2015-06-12
Decision Date2016-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630031726056 K151590 000
07630031726049 K151590 000

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