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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 K212983
Device Name Injectable Root Canal Bioceramic Sealer
Beijing C-Root Dental Medical Devices Co., LTD.
Room 301, Building 10, Yard 12, Middle Juyuan Road,
Mapo Town,Shunyi District
Beijing,  CN 101300
Applicant Contact Bingmin Wu
Shanghai Truthful Information Technology Co., Ltd.
RM.1801 ,No.161, East Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number872.3820
Classification Product Code
Date Received09/17/2021
Decision Date 12/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No