510(k) K251811

Motor and Apex Module (MaAM) by Dentsply Sirona, Inc. — Product Code EBW

K251811 is an FDA 510(k) premarket notification submitted by Dentsply Sirona, Inc. for the device "Motor and Apex Module (MaAM)". The FDA issued a decision of Substantially Equivalent on August 25, 2025. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Dentsply Sirona, Inc. has at least 10 other 510(k) clearances on record.