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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 K251232
Device Name MegaGen Zygoma Dental Implant System
Applicant
Megagen Implant Co., Ltd.
45, Secheon-Ro 7-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Applicant Contact Hyo-Eun Lee
Correspondent
Megagen Implant Co., Ltd.
45, Secheon-Ro 7-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Correspondent Contact Hyo-Eun Lee
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/22/2025
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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