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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 K230069
Device Name S.I.N. Dental Implant System
Applicant
S.I.N. – Sistema de Implante Nacional S.A.
Avenida Vereador Abel Ferreira, 1100
São Paulo,  BR 03340-000
Applicant Contact Denise Domiciano
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 Received01/10/2023
Decision Date 04/06/2023
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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