510(k) K251297

MIS LYNX Conical Connection Implant System by Dentsply Sirona, Inc. — Product Code DZE

K251297 is an FDA 510(k) premarket notification submitted by Dentsply Sirona, Inc. for the device "MIS LYNX Conical Connection Implant System". The FDA issued a decision of Substantially Equivalent on July 24, 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.