
Union Broach, Div. Moyco Industries, Inc.
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FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE is an FDA 510(k)-cleared medical device (K855136) manufactured by Union Broach, Div. Moyco Industries, Inc.. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 5, 1986. Regulation: 8.