510(k) K070483

LEONE MONOIMPLANT FOR O-RING OVERDENTURE by Leone S.P.A. — Product Code DZE

K070483 is an FDA 510(k) premarket notification submitted by Leone S.P.A. for the device "LEONE MONOIMPLANT FOR O-RING OVERDENTURE". The FDA issued a decision of Substantially Equivalent on April 19, 2007. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Leone S.P.A. has at least 3 other 510(k) clearances on record.