510(k) Report

Devices descending from K092141

8 later devices reach Vanish Varnish, 5% Sodium Fluoride White Varnish through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230333Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint…Kettenbach GmbH & Co. KG20230—
+1K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment3M Espe Dental Products20230—
+1K182917FluoroCalBisco, Inc.20190—
+1K151302Clinpro Varnish3M Company20150—
+1K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc.20140—
+1K131376Smartcoat 2.5% Naf VarnishElevate Oral Care20131—
+1K102808MI VarnishGC America, Inc.20100—
+2K250714FluoroDose VarnishCentrix, Inc.20250—