ST Internal 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 St Internal Implant System.

Pre-market Notification Details

Device IDK192347
501k NumberK192347
Device Name:ST Internal Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Megagen Implant Co. Ltd 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun Daegu,  KR 42921
ContactYou Jung Kim
CorrespondentYou Jung Kim
Megagen Implant Co. Ltd 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun Daegu,  KR 42921
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-29
Decision Date2019-11-14

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