510(k) K081287

SAPPHIRE PLASMA ARC DENTAL CURING LIGHT by Den-Mat Holdings, LLC — Product Code EBZ

K081287 is an FDA 510(k) premarket notification submitted by Den-Mat Holdings, LLC for the device "SAPPHIRE PLASMA ARC DENTAL CURING LIGHT". The FDA issued a decision of Substantially Equivalent on November 21, 2008. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Den-Mat Holdings, LLC has at least 7 other 510(k) clearances on record.