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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 K150182
Device Name Neodent Implant System- CM Drive Implants
Applicant
Jjgc Industria E Comercio DE Materiais Dentarios S
Av.P.Juscelino Kubitschek De
Oliveira 3291
Curitiba,  BR 81270-200
Applicant Contact Jacson Cambruzzi
Correspondent
Instradent USA
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Christopher Klaczyk
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/27/2015
Decision Date 04/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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