510(k) K021915

TRANSITIONAL IMPLANTS by Intra-Lock International — Product Code DZE

K021915 is an FDA 510(k) premarket notification submitted by Intra-Lock International for the device "TRANSITIONAL IMPLANTS". The FDA issued a decision of Substantially Equivalent on December 19, 2002. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Intra-Lock International has at least 10 other 510(k) clearances on record.