NEODENT IMPLANT SYSTEM

Implant, Endosseous, Root-form

JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S

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

Pre-market Notification Details

Device IDK141777
510k NumberK141777
Device Name:NEODENT IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 12264 EL CAMINO REAL, STE 400 San Diego,  CA  92130
ContactKevin A Thomas
CorrespondentKevin A Thomas
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 12264 EL CAMINO REAL, STE 400 San Diego,  CA  92130
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-02
Decision Date2015-07-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07899878006879 K141777 000
07899878006862 K141777 000
07899878006374 K141777 000
07899878006367 K141777 000
07899878006350 K141777 000
07899878005513 K141777 000
07899878005506 K141777 000
07899878005490 K141777 000

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