ALLROUND-E (CODE NAME RD 1710)

ALLROUND-E (CODE NAME RD 1710) is an FDA 510(k)-cleared medical device (K984587) 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 March 16, 1999. Regulation: 8.