510(k) K070538

XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE by Dentsply Intl. — Product Code KLE

K070538 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE". The FDA issued a decision of Substantially Equivalent on March 14, 2007. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Dentsply Intl. has at least 10 other 510(k) clearances on record.