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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K160964
Device Name Neodent Implant System - Titanium Base for CEREC
Applicant
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Av. Juscelino Kubitschek De Oliveira, 3291- Cic
Curitiba,  BR 8127 0-200
Applicant Contact JACSON Cambruzzi
Correspondent
Straumann USA, LLC
60-100 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact JENNIFER JACKSON
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/06/2016
Decision Date 09/16/2016
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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