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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K192347
Device Name ST Internal Implant System
Applicant
Megagen Implant Co., Ltd.
45, Secheon-Ro 7-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Applicant Contact You Jung Kim
Correspondent
Megagen Implant Co., Ltd.
45, Secheon-Ro 7-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Correspondent Contact You Jung Kim
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/29/2019
Decision Date 11/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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