510(k) K261485

Tetric plus Fill;Tetric plus Flow by Ivoclar Vivadent, Inc. — Product Code EBF

K261485 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, Inc. for the device "Tetric plus Fill;Tetric plus Flow". The FDA issued a decision of Substantially Equivalent on July 1, 2026. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Ivoclar Vivadent, Inc. has at least 10 other 510(k) clearances on record.