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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 K183024
Device Name Implacil Implant System
Applicant
Implacil de Bortoli Material Odontologico Ltda
Rua Vicente de Carvalho 178-182
Sao Paulo,  BR 01521020
Applicant Contact Thiago Toni
Correspondent
PR Servicos Regulatorios Administrativos Ltda
Rua Alice Além Saadi, 855/ 2402
Ribeirão Preto,  BR 14096-570
Correspondent Contact Janine Treter
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received11/01/2018
Decision Date 02/13/2020
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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