510(k) Report

Devices descending from K080249

7 later devices reach Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132109EnamelastUltradent Products Inc. / Oratech, LLC201342
+1K112946Activ VarnishPulpdent Corporation20111—
+2K253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.20260—
+2K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3%…Theodent, LLC20250—
+2K151302Clinpro Varnish3M Company20150—
+2K141422Profluoro Fluoride VarnishPac-Dent International, Inc.20140—
+2K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc.20140—