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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 K251129
Device Name S.I.N. Tapered Pro Conical Zygoma Implant System
Applicant
S.I.N. Implant System Ltda
Rua Soldado Ocimar Guimarães Da Silva, 421
São Paulo,  BR 03348-060
Applicant Contact Denise Domiciano
Correspondent
Michael Davis Quality and Regulatory Consulting, LLC
204 Norwick Forest Dr.
Alabaster,  AL  35007
Correspondent Contact Michael Davis
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/11/2025
Decision Date 11/07/2025
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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