DIAMOND (CODE NAME PT-054)

DIAMOND (CODE NAME PT-054) is an FDA 510(k)-cleared medical device (K960403) manufactured by J.F. Jelenko & Co., Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 25, 1996. Regulation: 8.