510(k) K222435

Renamel® Microhybrid ;Renamel® Flowable Microhybrid by Cosmedent, Inc. — Product Code EBF

K222435 is an FDA 510(k) premarket notification submitted by Cosmedent, Inc. for the device "Renamel® Microhybrid ;Renamel® Flowable Microhybrid". The FDA issued a decision of Substantially Equivalent on October 11, 2022. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Cosmedent, Inc. has at least 10 other 510(k) clearances on record.