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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 K173819
Device Name MyPlant II Implant System
Applicant
Hager& Meisinger GmbH
Hansemannstrasse 10
Neuss,  DE 41468
Applicant Contact Adam Tomczak
Correspondent
Hager& Meisinger GmbH
Hansemannstrasse 10
Neuss,  DE 41468
Correspondent Contact Adam Tomczak
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/18/2017
Decision Date 08/09/2018
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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