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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 K251046
Device Name S.I.N. Dental Implant System
Applicant
S.I.N. Implant System Ltda
Rua Soldado Ocimar Gumarães Da Silva, 421
São Paulo,  BR 03348-060
Applicant Contact Denise Domiciano
Correspondent
S.I.N. Implant System Ltda
Rua Soldado Ocimar Gumarães Da Silva, 421
São Paulo,  BR 03348-060
Correspondent Contact Denise Domiciano
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/03/2025
Decision Date 08/13/2025
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
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