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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 K162073
Device Name Dental Implants OKTAGON Tissue Level and Bone Level
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 Number872.3640
Classification Product Code
DZE  
Date Received07/27/2016
Decision Date 02/24/2017
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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