510(k) K213609

NOVA RESIN dual cure, self adhesive resin cement by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS — Product Code EMA

K213609 is an FDA 510(k) premarket notification submitted by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS for the device "NOVA RESIN dual cure, self adhesive resin cement". The FDA issued a decision of Substantially Equivalent on Aug 9, 2022. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Imicryl Dis Malzemeleri Sanayi VE Ticaret AS has 4 other 510(k) clearances on record.