510(k) K070693

AURAVUE PIT & FISSURE SEALANT by Denali Corporation — Product Code EBF

K070693 is an FDA 510(k) premarket notification submitted by Denali Corporation for the device "AURAVUE PIT & FISSURE SEALANT". The FDA issued a decision of Substantially Equivalent on May 9, 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.