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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K242030
Device Name MegaGen Dental Implant Abutment
Applicant
Megagen Implant Co., Ltd.
45, Secheon-Ro 7-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Applicant Contact Back Kyung-Hee
Correspondent
Megagen Implant Co., Ltd.
45, Secheon-Ro 7-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Correspondent Contact Back Kyung-Hee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/11/2024
Decision Date 01/13/2025
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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