510(k) K093518

ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM by Ace Surgical Supply Co., Inc. — Product Code DZE

K093518 is an FDA 510(k) premarket notification submitted by Ace Surgical Supply Co., Inc. for the device "ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on January 14, 2010. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Ace Surgical Supply Co., Inc. has at least 10 other 510(k) clearances on record.