510(k) K231578

Lucitone Digital Print Denture System by Dentsply Sirona — Product Code EBI

K231578 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "Lucitone Digital Print Denture System". The FDA issued a decision of Substantially Equivalent on October 20, 2023. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Dentsply Sirona has at least 10 other 510(k) clearances on record.