510(k) K212983

Injectable Root Canal Bioceramic Sealer by Beijing C-Root Dental Medical Devices Co., Ltd. — Product Code KIF

K212983 is an FDA 510(k) premarket notification submitted by Beijing C-Root Dental Medical Devices Co., Ltd. for the device "Injectable Root Canal Bioceramic Sealer". The FDA issued a decision of Substantially Equivalent on December 8, 2021. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Beijing C-Root Dental Medical Devices Co., Ltd. has at least 1 other 510(k) clearance on record.