510(k) K252450

Adhese 2 by Ivoclar Vivadent, Inc. — Product Code KLE

K252450 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, Inc. for the device "Adhese 2". The FDA issued a decision of Substantially Equivalent on March 5, 2026. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Ivoclar Vivadent, Inc. has at least 10 other 510(k) clearances on record.