510(k) K092912

STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 by Danville Materials, Inc. — Product Code EBF

K092912 is an FDA 510(k) premarket notification submitted by Danville Materials, Inc. for the device "STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150". The FDA issued a decision of Substantially Equivalent on December 16, 2009. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Danville Materials, Inc. has at least 10 other 510(k) clearances on record.