510(k) K162257

P1145 Dental Restorative by Kerr Corporation — Product Code EBF

K162257 is an FDA 510(k) premarket notification submitted by Kerr Corporation for the device "P1145 Dental Restorative". The FDA issued a decision of Substantially Equivalent on November 7, 2016. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Kerr Corporation has at least 10 other 510(k) clearances on record.