510(k) K182833

ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer by The Argen Corporation — Product Code EIH

K182833 is an FDA 510(k) premarket notification submitted by The Argen Corporation for the device "ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer". The FDA issued a decision of Substantially Equivalent on February 8, 2019. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. The Argen Corporation has at least 10 other 510(k) clearances on record.