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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 K160248
Device Name ArgenIS Titanium Abutments
Applicant
Argen Corporation
5855 Oberlin Dr
SAN DIEGO,  CA  92121
Applicant Contact Paul Cascone
Correspondent
Sterngold Dental, LLC
23 Frank Mossberg Drive
Attleboro,  MA  02703
Correspondent Contact Maria Rao
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/01/2016
Decision Date 08/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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