510(k) Report

Devices descending from K961893

6 later devices reach Duraflor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc.20140—
+1K113146PCXX VarnishRoss Healthcare, Inc.20120—
+1K102808MI VarnishGC America, Inc.20100—
+1K080814Voco Profluorid VarnishVoco GmbH20080—
+1K030488FluorilaqPascal Co., Inc.20032—
+2K090597Fluorilaq Sodium Fluoride Cavity VarnishPascal Co., Inc.20090—