510(k) Report

Devices descending from K990040

64 later devices reach Clearfil SE Bond through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070956SEA2 Self Etch Adhesive3M Espe Dental Products20070—
+1K063558Peak SE, Model 5135Ultradent Products, Inc.200602
+1K040952PreludeDanville Materials, Inc.20040—
+1K013519SimpleBisco, Inc.20020—
+1K012442Modification to Clearfil SE BondKuraray Medical, Inc.200160—
+2K131432Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Kuraray Noritake Dental, Inc.20131—
+2K063595Clearfil Majesty PosteriorKuraray America, Inc.20074—
+2K063593Clearfil Majesty FlowKuraray America, Inc.200717—
+2K061906Clearfil Ceramic PrimerKuraray Medical, Inc.20069—
+2K042929Estenia C&BKuraray Medical Kurashiki Plant200412—
+2K032455Panavia F 2.0Kuraray Medical, Inc.200334—
+2K024356Clearfil Silane KitKuraray Medical, Inc.20034—
+2K023842Clearfil SE Bond PlusKuraray Medical, Inc.20033—
+2K022999Clearfil AP-X PLT Intro KitKuraray Medical, Inc.20020—
+3K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited20230—
+3K183391Novidia Universal BondNobio, Ltd.20190—
+3K162967nuance UNIVERSALDen-Mat Holdings, LLC20170—
+3K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+3K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc.20150—
+3K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc.20154—
+3K133078K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc.20130—
+3K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc.20131—
+3K130371Clearfil Majesty ES FlowKuraray Noritake Dental, Inc.20130—
+3K122522Dentoetch Quickbond Bond ActivatorItena Clinical20130—
+3K121583Clearfil Majesty FlowKuraray Noritake Dental, Inc.20123—
+3K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc.20125—
+3K111982Clearfil DC Core PlusKuraray America, Inc.20116—
+3K111975Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKuraray Medical, Inc.20110—
+3K111980Clearfil Tri-S Bond PlusKuraray America, Inc.20114—
+3K110508Suglue-103M Espe AG20118—
+3K100908Unicem HM3M Espe AG Dental Products20101—
+3K100756MALTA3M Espe AG Dental Products201019—
+3K094007Unicem3M Espe AG Dental Products201022—
+3K100328Clearfil Majety PosteriorKuraray Medical, Inc.20100—
+3K091705Primer PlusBisco, Inc.20091—
+3K091300Ascent Porcelain Primer, Model 006-00078, 00600079CAO Group, Inc.20090—
+3K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+3K081583Clearfil SA CementKuraray Medical, Inc.20089—
+3K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc.20071—
+3K063228Surface CoatKuraray America, Inc.20060—
+3K062410Clearfil Esthetic Cement & DC BondKuraray Medical, Inc.200610—
+4K252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao Huge Biomaterials Company, Ltd.20250—
+4K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.20210—
+4K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseImicryl Dis Malzemeleri Sanayi VE Ticaret AS20210—
+4K192992Suglue 33M Deutschland GmbH20190—
+4K183465Allcem, Allcem CoreDentscare Ltda20190—
+4K191548Nexus Universal Self-CureKerr Corporation201901
+4K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG20190—
+4K182430Clearfil Majesty ICKuraray Noritake Dental, Inc.20190—
+4K183537PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc.20190—
+4K180802Meta P&BondMeta Biomed Co., Ltd.20180—
+4K171449MetacemMeta Biomed Co., Ltd.20181—
+4K170873Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi…Swissmeditec GmbH20170—
+4K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.20165—
+4K152691EDS Universal CementEssential Dental Systems, Inc.20160—
+4K131357PEAK ZUltradent Products, Inc.20130—
+4K120378Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix…Kuraray Medical, Inc.20121—
+4K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc.20090—
+5K261166Dia-CemDiaDent Group International20260—
+5K251946G aenial Universal Injectable IIGC America, Inc.20250—
+5K200798G-Cem OneGC America, Inc.20203—
+6K254109G-Cem UniversalGC America, Inc.20260—
+6K254063iCEM Universal PlusKulzer, LLC20250—
+6K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment…Overfibers S.R.L.20250—