510(k) K092616

ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 by CAO Group, Inc. — Product Code KLE

K092616 is an FDA 510(k) premarket notification submitted by CAO Group, Inc. for the device "ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045". The FDA issued a decision of Substantially Equivalent on October 21, 2009. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. CAO Group, Inc. has at least 10 other 510(k) clearances on record.