Neodent Implant System - GM Helix Implants 7.0

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 - Gm Helix Implants 7.0.

Pre-market Notification Details

Device IDK201225
510k NumberK201225
Device Name:Neodent Implant System - GM Helix Implants 7.0
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-06
Decision Date2020-09-04

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