Advanced Intermezzo Implant System

Implant, Endosseous, Root-form

MegaGen Implant Co., Ltd.

The following data is part of a premarket notification filed by Megagen Implant Co., Ltd. with the FDA for Advanced Intermezzo Implant System.

Pre-market Notification Details

Device IDK191127
510k NumberK191127
Device Name:Advanced Intermezzo Implant System
ClassificationImplant, Endosseous, Root-form
Applicant MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun Daegu,  KR
ContactJiyoung Son
CorrespondentJiyoung Son
MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun Daegu,  KR
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-29
Decision Date2019-10-08
Summary:summary

NIH GUDID Devices

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