510(k) K240823

els extra low shrinkage® composite & els extra low shrinkage® flow by Saremco Dental AG — Product Code EBF

K240823 is an FDA 510(k) premarket notification submitted by Saremco Dental AG for the device "els extra low shrinkage® composite & els extra low shrinkage® flow". The FDA issued a decision of Substantially Equivalent on June 27, 2024. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Saremco Dental AG has at least 3 other 510(k) clearances on record.