510(k) K251587

VITA VMLC Primer by Vita Zahnfabrik H. Rauter GmbH & Co. Kg. — Product Code KLE

K251587 is an FDA 510(k) premarket notification submitted by Vita Zahnfabrik H. Rauter GmbH & Co. Kg. for the device "VITA VMLC Primer". The FDA issued a decision of Substantially Equivalent on February 23, 2026. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Vita Zahnfabrik H. Rauter GmbH & Co. Kg. has at least 1 other 510(k) clearance on record.