510(k) K970776

LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT by Lifecore Biomedical, Inc. — Product Code DZE

K970776 is an FDA 510(k) premarket notification submitted by Lifecore Biomedical, Inc. for the device "LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT". The FDA issued a decision of Substantially Equivalent on May 27, 1997. 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.