AnyOne External 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 Anyone External Implant System.

Pre-market Notification Details

Device IDK203554
510k NumberK203554
Device Name:AnyOne External Implant System
ClassificationImplant, Endosseous, Root-form
Applicant MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil Daegu,  KR 42921
ContactYou Jung Kim
CorrespondentYou Jung Kim
DaeGyeong Regulatory Affairs Institute 32, Innovalley-ro Daegu,  KR 41065
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-04
Decision Date2021-08-28

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