510(k) Report

Devices descending from K023814

12 later devices reach Gradia Direct through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061860Clearfil Majesty EstheticKuraray Medical, Inc.200611—
+2K192178R&D Series Nova Compo NImicryl Dis Malzemeleri Sanayi VE Ticaret AS20190—
+2K121583Clearfil Majesty FlowKuraray Noritake Dental, Inc.20123—
+2K070325Clearfil Majesty Esthetic PLTKuraray Medical, Inc.20070—
+2K063595Clearfil Majesty PosteriorKuraray America, Inc.20074—
+3K182430Clearfil Majesty ICKuraray Noritake Dental, Inc.20190—
+3K170873Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi…Swissmeditec GmbH20170—
+3K162967nuance UNIVERSALDen-Mat Holdings, LLC20170—
+3K130371Clearfil Majesty ES FlowKuraray Noritake Dental, Inc.20130—
+3K100328Clearfil Majety PosteriorKuraray Medical, Inc.20100—
+3K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc.20071—
+4K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc.20090—