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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 K220562
Device Name TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment
Applicant
Megagen Implant Co., Ltd.
45, Secheon-Ro, 7-Gil
Daegu,  KR 42921
Applicant Contact Hyo-Eun Lee
Correspondent
Daegyeong Regulatory Affairs Institute
45, Secheon-Ro, 7-Gil
Dasa-Eup, Dalseong-Gun
Daegu,  KR 42921
Correspondent Contact Hyo-Eun Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/28/2022
Decision Date 11/10/2022
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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