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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 K141159
Device Name KONUS DENTAL IMPLANT SYSTEM
Applicant
Argon Med. Productions Vertriebs Gesellschaft Mbh
1000 Corporate Dr.
Marshfield,  WI  54449
Applicant Contact LINDA SAYLOR
Correspondent
Argon Med. Productions Vertriebs Gesellschaft Mbh
1000 Corporate Dr.
Marshfield,  WI  54449
Correspondent Contact LINDA SAYLOR
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/05/2014
Decision Date 03/11/2015
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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