NEODENT IMPLANT SYSTEM

Abutment, Implant, Dental, Endosseous

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 IDK133696
510k NumberK133696
Device Name:NEODENT IMPLANT SYSTEM
ClassificationAbutment, Implant, Dental, Endosseous
Applicant JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 11234 EL CAMINO REAL SUITE 200 San Diego,  CA  92130
ContactKevin A Thomas
CorrespondentKevin A Thomas
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 11234 EL CAMINO REAL SUITE 200 San Diego,  CA  92130
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-03
Decision Date2014-02-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07899878005193 K133696 000
07898237561127 K133696 000
07898237561134 K133696 000
07898237561141 K133696 000
07898237561158 K133696 000
07899878005100 K133696 000
07899878005117 K133696 000
07899878005124 K133696 000
07899878005131 K133696 000
07899878005148 K133696 000
07899878005155 K133696 000
07899878005162 K133696 000
07899878005179 K133696 000
07899878005186 K133696 000
07898237561110 K133696 000

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