510(k) K251647

MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System by Dentsply Sirona, Inc. — Product Code DZE

K251647 is an FDA 510(k) premarket notification submitted by Dentsply Sirona, Inc. for the device "MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System". The FDA issued a decision of Substantially Equivalent on August 21, 2025. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Dentsply Sirona, Inc. has at least 10 other 510(k) clearances on record.