SMARTLITE PS PEN-STYLE LED CURING LIGHT

SMARTLITE PS PEN-STYLE LED CURING LIGHT is an FDA 510(k)-cleared medical device (K041372) manufactured by Dentsply International. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 2004. Regulation: 8.