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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K133592
Device Name NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM
Applicant
Neodent USA, Inc.
60 Minuteman Rd.
Andover,  MA  01810
Applicant Contact CHRISTOPHER KLACZYK
Correspondent
Neodent USA, Inc.
60 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact CHRISTOPHER KLACZYK
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/22/2013
Decision Date 08/22/2014
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
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