PANASIL INITIAL CONTACT AND PANASIL TRAY

PANASIL INITIAL CONTACT AND PANASIL TRAY is an FDA 510(k)-cleared medical device (K083701) manufactured by Kettenbach GmbH & Co. KG. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 8, 2009. Regulation: 8.