BW-1 (CODE NAME RD-0807)

BW-1 (CODE NAME RD-0807) is an FDA 510(k)-cleared medical device (K981244) 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 August 12, 1998. Regulation: 8.