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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 K163350
Device Name Multibase Abutments EV and ATLANTIS Suprastructures
Applicant
DENTSPLY SIRONA
221 WEST PHILADELPHIA STREET
SUITE 60
York,  PA  17404
Applicant Contact KARL NITTINGER
Correspondent
DENTSPLY SIRONA
221 WEST PHILADELPHIA STREET
SUITE 60
York,  PA  17404
Correspondent Contact KARL NITTINGER
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/30/2016
Decision Date 03/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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