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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 K180184
Device Name Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
Applicant
Dentalpoint AG
Bodenackerstrasse 5
Spreitenbach,  CH 8957
Applicant Contact Anja Lieberherr
Correspondent
Mapi USA, Inc.
2343 Alexandria Dirve
Suite 100
Lexington,  KY  40504
Correspondent Contact Elizabeth Rose
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
DZE  
Date Received01/23/2018
Decision Date 11/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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