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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 K113404
Device Name DENTAL 3D PLANNING SOFTWARE
Original Applicant
SYMBYO DENTAL, LLC
87 hulme ct apt.216
stanford,  CA  94305
Original Contact parul chansoria
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/18/2011
Decision Date 12/06/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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