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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 K163194
Device Name Neodent Implant System - GM Line
Applicant
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA
AV. JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 - CIC
CURITIBA,  BR 81270-200
Applicant Contact Julianne Lechechem
Correspondent
STRAUMANN USA, INC.
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received11/15/2016
Decision Date 07/14/2017
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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