Abutment For Bridges

Abutment, Implant, Dental, Endosseous

ALTATEC GmbH

The following data is part of a premarket notification filed by Altatec Gmbh with the FDA for Abutment For Bridges.

Pre-market Notification Details

Device IDK153779
510k NumberK153779
Device Name:Abutment For Bridges
ClassificationAbutment, Implant, Dental, Endosseous
Applicant ALTATEC GmbH Maybachstrasse 5 Wimsheim,  DE D-71299
ContactColleen Boswell
CorrespondentLinda Schulz
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-31
Decision Date2016-03-31

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