510(k) Report

Devices descending from K090519

3 later devices reach Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5%… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100540Ascent F-Coat Model: 006-00097CAO Group, Inc.20102—
+2K103160Nupro Model 13016901CAO Group, Inc.20111—
+3K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc.20140—