510(k) K240743

Peak Universal Bond by Ultradent Products, Inc. — Product Code KLE

K240743 is an FDA 510(k) premarket notification submitted by Ultradent Products, Inc. for the device "Peak Universal Bond". The FDA issued a decision of Substantially Equivalent on March 20, 2024. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Ultradent Products, Inc. has at least 10 other 510(k) clearances on record.