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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
Curitiba,  BR 8127 0-200
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
Predetermined Change
Control Plan Authorized		 No
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