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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 K153779
Device Name Abutment for Bridges
Applicant
Altatec GmbH
Maybachstrasse 5
Wimsheim,  DE D-71299
Applicant Contact Colleen Boswell
Correspondent
PaxMed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Linda Schulz
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/31/2015
Decision Date 03/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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