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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 K160244
Device Name VARIOunite
Applicant
Thommen Medical AG
Neckarsulmstrasse 28
Grenchen,  CH 2540
Applicant Contact Daniel Snetivy
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 Received02/01/2016
Decision Date 06/02/2016
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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