510(k) K231263

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT by Prevest Denpro Limited — Product Code EBF

K231263 is an FDA 510(k) premarket notification submitted by Prevest Denpro Limited for the device "Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT". The FDA issued a decision of Substantially Equivalent on January 5, 2024. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Prevest Denpro Limited has at least 6 other 510(k) clearances on record.