Neodent 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 Neodent Implant System.

Pre-market Notification Details

Device IDK190958
501k NumberK190958
Device Name:Neodent 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
ContactMariana Soares Hartmann
CorrespondentJennifer M. Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  MA  01810
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-12
Decision Date2019-11-09

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