510(k) K231696

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal by Prevest Denpro Limited — Product Code KLE

K231696 is an FDA 510(k) premarket notification submitted by Prevest Denpro Limited for the device "Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal". The FDA issued a decision of Substantially Equivalent on August 11, 2023. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Prevest Denpro Limited has at least 6 other 510(k) clearances on record.