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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 K202832
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
Implacil DE Bortoli Material Odontologico Ltda
Rua Vicente De Carvalho 178-182
Sao Paulo,  BR 01521020
Correspondent Contact Thiago Toni
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/25/2020
Decision Date 05/26/2021
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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