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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 K160132
Device Name Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC
Applicant
Hager& Meisinger GmbH
Hansemannstrasse 10
Neuss,  DE 41468
Applicant Contact Melanie May
Correspondent
Hager& Meisinger GmbH
Hansemannstrasse 10
Neuss,  DE 41468
Correspondent Contact Melanie May
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/20/2016
Decision Date 11/21/2016
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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