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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 K233450
Device Name MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw
Applicant
Megagen Implant Co., Ltd.
45, Secheon-Ro 7-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Applicant Contact Seo MinGi
Correspondent
Megagen Implant Co., Ltd.
45, Secheon-Ro 7-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Correspondent Contact Seo MinGi
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/20/2023
Decision Date 01/22/2024
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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