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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 K171115
Device Name 3D Endo Software
Applicant
Dentsply Sirona
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Applicant Contact Karl Nittinger
Correspondent
Dentsply Sirona
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Correspondent Contact Karl Nittinger
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/14/2017
Decision Date 07/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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