Neodent Implant System - Temporary Abutments

Abutment, Implant, Dental, Endosseous

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 - Temporary Abutments.

Pre-market Notification Details

Device IDK191191
510k NumberK191191
Device Name:Neodent Implant System - Temporary Abutments
ClassificationAbutment, Implant, Dental, Endosseous
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 CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-03
Decision Date2019-12-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07899878033257 K191191 000
07899878033110 K191191 000
07899878033127 K191191 000
07899878033134 K191191 000
07899878033141 K191191 000
07899878033158 K191191 000
07899878033165 K191191 000
07899878033172 K191191 000
07899878033189 K191191 000
07899878033196 K191191 000
07899878033202 K191191 000
07899878033219 K191191 000
07899878033226 K191191 000
07899878033233 K191191 000
07899878033240 K191191 000
07899878033103 K191191 000

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