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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K261728
Device Name One-Fil LC
Applicant
Mediclus Co., Ltd.
# 1210, 134, Gongdan-Ro, Heungdeok-Gu
Cheongju-Si,  KR 28576
Applicant Contact Ku Da Hyeon
Correspondent
Mediclus Co., Ltd.
# 1210, 134, Gongdan-Ro, Heungdeok-Gu
Cheongju-Si,  KR 28576
Correspondent Contact Ku Da Hyeon
Regulation Number872.3250
Classification Product Code
EJK  
Date Received05/26/2026
Decision Date 07/21/2026
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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