510(k) K240365

Bioceramic Root Repair Material (C-Root BP) by Beijing C-Root Dental Medical Devices Co., Ltd. — Product Code KIF

K240365 is an FDA 510(k) premarket notification submitted by Beijing C-Root Dental Medical Devices Co., Ltd. for the device "Bioceramic Root Repair Material (C-Root BP)". The FDA issued a decision of Substantially Equivalent on May 10, 2024. 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.