510(k) Report

Devices descending from K051750

8 later devices reach Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080249Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505Ultradent Products, Inc.20087—
+2K132109EnamelastUltradent Products Inc. / Oratech, LLC201342
+2K112946Activ VarnishPulpdent Corporation20111—
+3K253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.20260—
+3K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3%…Theodent, LLC20250—
+3K151302Clinpro Varnish3M Company20150—
+3K141422Profluoro Fluoride VarnishPac-Dent International, Inc.20140—
+3K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc.20140—