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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 K222231
Device Name S.I.N. Dental Implant System
Applicant
S.I.N. - Sistema de Implante Nacional S.A.
Avenida Vereador Abel Ferreira, 1100
Sao 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 Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/25/2022
Decision Date 10/27/2022
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
Recalls CDRH Recalls
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