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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K170272
Device Name TruMatch CMF Titanium 3D Printed Implant System
Applicant
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Lina Ramirez
Correspondent
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Lina Ramirez
Regulation Number872.4760
Classification Product Code
JEY  
Date Received01/30/2017
Decision Date 08/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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