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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K143337
Device Name CONELOG Titanium base CAD/CAM
Applicant
ALTATEC GMBH
Maybachstrasse 5
Wimsheim,  DE D-71299
Applicant Contact DENNIS PAPPAS
Correspondent
PAXMED INTERNATIONAL, LLC
12264 EL CAMINO REAL
SUITE 400
SAN DIEGO,  CA  92130
Correspondent Contact LINDA K SCHULZ
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/20/2014
Decision Date 02/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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