Neodent Implant System - Zirconia Implant System

Abutment, Implant, Dental, Endosseous

JJGC Industria E Comercio De Materiais Dentarios SA

The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios Sa with the FDA for Neodent Implant System - Zirconia Implant System.

Pre-market Notification Details

Device IDK202282
510k NumberK202282
Device Name:Neodent Implant System - Zirconia Implant System
ClassificationAbutment, Implant, Dental, Endosseous
Applicant JJGC Industria E Comercio De Materiais Dentarios SA Av. Juscelino Kubitschek De Oliveira, 3291 – CIC Curitiba,  BR 81270-200
ContactMariana Soares Hartmann
CorrespondentJennifer M. Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  MA  01810
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-12
Decision Date2021-01-29

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