510(k) K200625

I-View Gold and Imagen Gold Dental Sensors by Trident S.R.L — Product Code MUH

K200625 is an FDA 510(k) premarket notification submitted by Trident S.R.L for the device "I-View Gold and Imagen Gold Dental Sensors". The FDA issued a decision of Substantially Equivalent on April 15, 2020. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Trident S.R.L has at least 4 other 510(k) clearances on record.