PAGALINOR 4 , ALLOY NO. 5440

PAGALINOR 4 , ALLOY NO. 5440 is an FDA 510(k)-cleared medical device (K993506) manufactured by Metalor Dental USA Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 7, 1999. Regulation: 8.