510(k) K062542

Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX by Z-Systems AG — Product Code DZE

K062542 is an FDA 510(k) premarket notification submitted by Z-Systems AG for the device "Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX". The FDA issued a decision of Substantially Equivalent on Oct 29, 2007. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Z-Systems AG has 8 other 510(k) clearances on record.