510(k) Report

Devices descending from K012740

35 later devices reach Clearfil AP-X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+1K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc.20150—
+1K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc.20154—
+1K133078K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc.20130—
+1K111982Clearfil DC Core PlusKuraray America, Inc.20116—
+1K063595Clearfil Majesty PosteriorKuraray America, Inc.20074—
+1K063593Clearfil Majesty FlowKuraray America, Inc.200717—
+1K061860Clearfil Majesty EstheticKuraray Medical, Inc.200611—
+1K042124DenfilVericom Co., Ltd.20044—
+1K023002Clearfil AP-X PLTKuraray Medical, Inc.20029—
+1K022999Clearfil AP-X PLT Intro KitKuraray Medical, Inc.20020—
+2K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.20210—
+2K193496CharmFilDentkist, Inc.20200—
+2K192510DIAFIL & DIAFIL CapsuleDiaDent Group International20202—
+2K192178R&D Series Nova Compo NImicryl Dis Malzemeleri Sanayi VE Ticaret AS20190—
+2K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG20190—
+2K183537PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc.20190—
+2K162967nuance UNIVERSALDen-Mat Holdings, LLC20170—
+2K130371Clearfil Majesty ES FlowKuraray Noritake Dental, Inc.20130—
+2K121583Clearfil Majesty FlowKuraray Noritake Dental, Inc.20123—
+2K111975Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKuraray Medical, Inc.20110—
+2K111980Clearfil Tri-S Bond PlusKuraray America, Inc.20114—
+2K100328Clearfil Majety PosteriorKuraray Medical, Inc.20100—
+2K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc.20071—
+2K070325Clearfil Majesty Esthetic PLTKuraray Medical, Inc.20070—
+2K033970Clearfil Photo Core PLTKuraray Medical, Inc.20040—
+3K261093DiafilDiaDent Group International20260—
+3K210421Diafil & Diafil CapsuleDiaDent Group International20210—
+3K182430Clearfil Majesty ICKuraray Noritake Dental, Inc.20190—
+3K170873Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi…Swissmeditec GmbH20170—
+3K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc.20131—
+3K131432Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Kuraray Noritake Dental, Inc.20131—
+3K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc.20090—
+4K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited20230—
+4K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseImicryl Dis Malzemeleri Sanayi VE Ticaret AS20210—