510(k) Report

Devices descending from K082198

4 later devices reach Durashield Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103160Nupro Model 13016901CAO Group, Inc.20111—
+1K100540Ascent F-Coat Model: 006-00097CAO Group, Inc.20102—
+1K090519Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride…3M Company20093—
+2K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc.20140—