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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 K170398
Device Name S.I.N. Dental Implant System
S.I.N. – Sistema de Implante Nacional S.A.
Avenida Vereador Abel Ferreira, 1100
Sao Paulo,  BR 03310-000
Applicant Contact Denis Oliveira
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Linda K. Schulz
Regulation Number872.3640
Classification Product Code
Subsequent Product Code
Date Received02/09/2017
Decision Date 11/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No