510(k) Report

Devices descending from K002581

3 later devices reach Duragard Sodium Fluoride Varnish through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031932Fluoride VarnishDentsply Intl.20032—
+2K122331Cavity VarnishDentsply International, Inc.20120—
+2K080814Voco Profluorid VarnishVoco GmbH20080—