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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 K113739
Device Name SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM
Original Applicant
MATERIALISE DENTAL NV
technologielaan 15
leuven,  BE 3001
Original Contact geert appeltans
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
DZE   EBG  
Date Received12/20/2011
Decision Date 05/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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