510(k) Report

Devices descending from K132109

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

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