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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K252246
Device Name Leforte MMF System
Applicant
Jeil Medical Corporation
702•703•704•705•706•707•804•805•807•812•815-Ho, 55
Digital-Ro 34-Gil, Guro-Gu
Seoul,  KR 08378
Applicant Contact Jinwoo Kim
Correspondent
Jeil Medical Corporation
702•703•704•705•706•707•804•805•807•812•815-Ho, 55
Digital-Ro 34-Gil, Guro-Gu
Seoul,  KR 08378
Correspondent Contact Jinwoo Kim
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
DZL  
Date Received07/18/2025
Decision Date 04/02/2026
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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