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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K161118
Device Name SIMPLANT Online Case Review and SIMPLANT Editor
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 Number892.2050
Classification Product Code
LLZ  
Date Received04/20/2016
Decision Date 07/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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