510(k) K251084

zirkon; structure; LFU shades, stains and glazes by Estetic Ceram AG — Product Code EIH

K251084 is an FDA 510(k) premarket notification submitted by Estetic Ceram AG for the device "zirkon; structure; LFU shades, stains and glazes". The FDA issued a decision of Substantially Equivalent on June 5, 2025. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660.