510(k) K070702

FUSION RESIN CEMENT AND CORE KIT by Denali Corporation — Product Code EBF

K070702 is an FDA 510(k) premarket notification submitted by Denali Corporation for the device "FUSION RESIN CEMENT AND CORE KIT". The FDA issued a decision of Substantially Equivalent on May 10, 2007. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Denali Corporation has at least 8 other 510(k) clearances on record.