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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 K150367
Device Name Neodent Implant System
Applicant
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S
AV. JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 - CIC
CURTIBA,  BR 81270-200
Applicant Contact Jacson Cambruzzi
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A Thomas
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/12/2015
Decision Date 07/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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