510(k) K841111

REMBRANDT SHADE MODIFICATION KIT by Den-Mat Corp. — Product Code EBF

K841111 is an FDA 510(k) premarket notification submitted by Den-Mat Corp. for the device "REMBRANDT SHADE MODIFICATION KIT". The FDA issued a decision of Substantially Equivalent on March 30, 1984. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Den-Mat Corp. has at least 10 other 510(k) clearances on record.