CLEARFIL TRI-S BOND SINGLE DOSE

CLEARFIL TRI-S BOND SINGLE DOSE is an FDA 510(k)-cleared medical device (K051796) manufactured by Kuraray Medical Kurashiki Plant. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 8, 2005. Regulation: 8.