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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 K143051
Device Name ArgenIS Titanium Abutments
Applicant
The Argen Corporation
5855 Oberlin Dr.
San Diego,  CA  92121
Applicant Contact Maria Rao
Correspondent
The Argen Corporation
5855 Oberlin Dr.
San Diego,  CA  92121
Correspondent Contact Maria Rao
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/23/2014
Decision Date 09/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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