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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K251884
Device Name One-Fil Putty Injectable
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 Number872.3820
Classification Product Code
KIF  
Date Received06/20/2025
Decision Date 08/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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