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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 K160626
Device Name ATLANTIS Abutment for HIOSSEN ET implant
Applicant
DENTSPLY SIRONA
221 WEST PHILADELPHIA STREET
SUITE 60
York,  PA  17404
Applicant Contact Helen Lewis
Correspondent
DENTSPLY SIRONA
221 WEST PHILADELPHIA STREET
SUITE 60
York,  PA  17404
Correspondent Contact Helen Lewis
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/07/2016
Decision Date 08/29/2016
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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