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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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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