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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K160581
Device Name K3PRO Konus Additional Abutments and Implants
Applicant
Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG
Mainzer St. 346
Bingen Am Rhein,  DE 55411
Applicant Contact RICHARD DONACA
Correspondent
Argon Medical USA, LLC
1000 Corporate Dr.
Marshfield,  WI  54449
Correspondent Contact LINDA SAYLOR
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/01/2016
Decision Date 03/24/2017
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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