510(k) K243621

Evoblock, Perléon by Evoden Indústria Comércio Importação E Exportação — Product Code EBG

K243621 is an FDA 510(k) premarket notification submitted by Evoden Indústria Comércio Importação E Exportação for the device "Evoblock, Perléon". The FDA issued a decision of Substantially Equivalent on April 22, 2025. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770.