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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 K223339
Device Name Bone Chamber Implant
Applicant
Megagen Implant Co., Ltd.
45, Secheon-Ro, 7-Gil
Daegu,  KR 42921
Applicant Contact Eun Mi Park
Correspondent
Megagen Implant Co., Ltd.
45, Secheon-Ro, 7-Gil
Daegu,  KR 42921
Correspondent Contact Eun Mi Park
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/01/2022
Decision Date 07/18/2023
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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