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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 K133510
Device Name NEODENT IMPLANT SYSTEM
Applicant
Jj Industria E Comercio DE Materiais Dentarios SA
11264 El Camino Real, Suite 400
San Diego,  CA  92130
Applicant Contact KEVIN A THOMAS
Correspondent
Jj Industria E Comercio DE Materiais Dentarios SA
11264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact KEVIN A THOMAS
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received11/14/2013
Decision Date 02/24/2014
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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