510(k) K072768

RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS by Lifecore Biomedical, Inc. — Product Code DZE

K072768 is an FDA 510(k) premarket notification submitted by Lifecore Biomedical, Inc. for the device "RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS". The FDA issued a decision of Substantially Equivalent on October 23, 2007. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Lifecore Biomedical, Inc. has at least 10 other 510(k) clearances on record.