510(k) K251465

Root canal repair materials (nRoot BP) by Enpuno Biotechnology Co., Ltd. — Product Code KIF

K251465 is an FDA 510(k) premarket notification submitted by Enpuno Biotechnology Co., Ltd. for the device "Root canal repair materials (nRoot BP)". The FDA issued a decision of Substantially Equivalent on September 25, 2025. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Enpuno Biotechnology Co., Ltd. has at least 1 other 510(k) clearance on record.