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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 K150199
Device Name Neodent Implant System
Applicant
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S
AVE JUSCELINO KUBITSCHEK DE
OLIVEIRA 3291-CIC
CURITIBA,  BR 81270
Applicant Contact Jacson Cambruzzi
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A Thomas
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/29/2015
Decision Date 06/15/2015
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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