510(k) K033699

LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 by Zest Anchors, Inc. — Product Code DZE

K033699 is an FDA 510(k) premarket notification submitted by Zest Anchors, Inc. for the device "LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586". The FDA issued a decision of Substantially Equivalent on April 22, 2004. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Zest Anchors, Inc. has at least 10 other 510(k) clearances on record.