NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS

Abutment, Implant, Dental, Endosseous

STRAUMANN USA

The following data is part of a premarket notification filed by Straumann Usa with the FDA for Narrow Connection Straumann Anatomic Ips E.max Abutments.

Pre-market Notification Details

Device IDK110580
510k NumberK110580
Device Name:NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant STRAUMANN USA 60 MINUTEMAN ROAD Andover,  MA  01810
ContactElaine Alan
CorrespondentElaine Alan
STRAUMANN USA 60 MINUTEMAN ROAD Andover,  MA  01810
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-01
Decision Date2011-08-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630031708588 K110580 000
07630031708571 K110580 000
07630031708564 K110580 000
07630031708557 K110580 000
07630031708540 K110580 000
07630031708533 K110580 000
07630031708526 K110580 000
07630031708519 K110580 000

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