510(k) K212103

StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 by Fona S.R.L — Product Code MUH

K212103 is an FDA 510(k) premarket notification submitted by Fona S.R.L for the device "StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2". The FDA issued a decision of Substantially Equivalent on Aug 30, 2021. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Fona S.R.L has 3 other 510(k) clearances on record.