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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 K163043
Device Name Zeramex P6 Dental Implant System
Applicant
Dentalpoint AG
Hohlstrasse 614
Zurich,  CH 8048
Applicant Contact Viktor Lienhard
Correspondent
Mapi USA, Inc.
2343 Alexandria Dr., Suite 100
Lexington,  KY  40504
Correspondent Contact Roshana Ahmed
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/31/2016
Decision Date 11/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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