SAPPHIRE PLASMA ARC DENTAL CURING LIGHT

SAPPHIRE PLASMA ARC DENTAL CURING LIGHT is an FDA 510(k)-cleared medical device (K081287) manufactured by Den-Mat Holdings, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 2008. Regulation: 8.