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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 K240365
Device Name Bioceramic Root Repair Material (C-Root BP)
Applicant
Beijing C-Root Dental Medical Devices Co., Ltd.
Rm. 301, Bldg. 10, Yard 12
Middle Juyuan Rd., Mapo Town, Shunyi
Beijing,  CN 101300
Applicant Contact Bingmin Wu
Correspondent
Beijing C-Root Dental Medical Devices Co., Ltd.
Rm. 301, Bldg. 10, Yard 12
Middle Juyuan Rd., Mapo Town, Shunyi
Beijing,  CN 101300
Correspondent Contact Bingmin Wu
Regulation Number872.3820
Classification Product Code
KIF  
Date Received02/06/2024
Decision Date 05/10/2024
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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