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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 K180536
Device Name Neodent Implant System – GM Line
JJGC Industria e Comercio de Materiais Dentarios S.A.
Av. Juscelino Kubitschek de Oliveira, 3291 – CIC
curitiba,  BR 81270-200
Applicant Contact julianne de oliveira capucho lechechem
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact kevin a. thomas
Regulation Number872.3640
Classification Product Code
Subsequent Product Code
Date Received02/28/2018
Decision Date 08/30/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No