NUVO IF Implant System

Implant, Endosseous, Root-form

JJGC Industria E Comercio De Materiais Dentarios S.A.

The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios S.a. with the FDA for Nuvo If Implant System.

Pre-market Notification Details

Device IDK193234
510k NumberK193234
Device Name:NUVO IF Implant System
ClassificationImplant, Endosseous, Root-form
Applicant JJGC Industria E Comercio De Materiais Dentarios S.A. Av. Juscelino Kubitschek De Oliveira, 3291 - CIC Curitiba,  BR 81270-200
ContactLuiza Vaccari Toppel
CorrespondentJennifer M. Jackson
Straumann USA LLC 60 Minuteman Road Andover,  MA  01810
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-25
Decision Date2020-06-18

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