510(k) K191548

Nexus Universal Self-Cure by Kerr Corporation — Product Code EMA

K191548 is an FDA 510(k) premarket notification submitted by Kerr Corporation for the device "Nexus Universal Self-Cure". The FDA issued a decision of Substantially Equivalent on October 11, 2019. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Kerr Corporation has at least 10 other 510(k) clearances on record.