Implacil Implant System

Implant, Endosseous, Root-form

Implacil De Bortoli Material Odontologico Ltda

The following data is part of a premarket notification filed by Implacil De Bortoli Material Odontologico Ltda with the FDA for Implacil Implant System.

Pre-market Notification Details

Device IDK202832
510k NumberK202832
Device Name:Implacil Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Implacil De Bortoli Material Odontologico Ltda Rua Vicente De Carvalho 178-182 Sao Paulo,  BR 01521020
ContactThiago Toni
CorrespondentThiago Toni
Implacil De Bortoli Material Odontologico Ltda Rua Vicente De Carvalho 178-182 Sao Paulo,  BR 01521020
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-25
Decision Date2021-05-26

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