510(k) K240304

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) by Enpuno Biotechnology Co., Ltd. — Product Code KIF

K240304 is an FDA 510(k) premarket notification submitted by Enpuno Biotechnology Co., Ltd. for the device "Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)". The FDA issued a decision of Substantially Equivalent on May 28, 2024. 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.