510(k) K210804

Adhese Universal DC, Cention Primer by Ivoclar Vivadent, AG — Product Code KLE

K210804 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, AG for the device "Adhese Universal DC, Cention Primer". The FDA issued a decision of Substantially Equivalent on June 7, 2022. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Ivoclar Vivadent, AG has at least 10 other 510(k) clearances on record.