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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 K112679
Device Name SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM
Applicant
Materialise Dental NV
Technologielaan 15
Leuven,  BE 3001
Applicant Contact CARL VAN LIERDE
Correspondent
Materialise Dental NV
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact CARL VAN LIERDE
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
DZA   NDP   NOF  
Date Received09/14/2011
Decision Date 02/22/2012
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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