510(k) K240660

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active by Kulzer, LLC — Product Code EBF

K240660 is an FDA 510(k) premarket notification submitted by Kulzer, LLC for the device "Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active". The FDA issued a decision of Substantially Equivalent on September 17, 2024. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Kulzer, LLC has at least 10 other 510(k) clearances on record.