510(k) K251148

JDEvolution Plus L and JDEvolution Plus LE by Jdentalcare Srl — Product Code DZE

K251148 is an FDA 510(k) premarket notification submitted by Jdentalcare Srl for the device "JDEvolution Plus L and JDEvolution Plus LE". The FDA issued a decision of Substantially Equivalent on Sep 25, 2025. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Jdentalcare Srl has at least 4 other 510(k) clearances on record.