510(k) K092501

LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL by Novocol, Inc. — Product Code EBF

K092501 is an FDA 510(k) premarket notification submitted by Novocol, Inc. for the device "LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL". The FDA issued a decision of Substantially Equivalent on November 12, 2009. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Novocol, Inc. has at least 8 other 510(k) clearances on record.