510(k) K062636

OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS by Implant Innovations, Inc. — Product Code DZE

K062636 is an FDA 510(k) premarket notification submitted by Implant Innovations, Inc. for the device "OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS". The FDA issued a decision of Substantially Equivalent on June 1, 2007. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Implant Innovations, Inc. has at least 10 other 510(k) clearances on record.