510(k) Report

Devices descending from K042913

26 later devices reach Clearfil Tri-S Bond through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+1K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc.20131—
+1K111975Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKuraray Medical, Inc.20110—
+1K111980Clearfil Tri-S Bond PlusKuraray America, Inc.20114—
+1K110403Prolink Adhesives (Prolink, Prolink SE)Silmet, Ltd.20111—
+1K082753Futurabond M/Futurabond M Single DoseVoco GmbH20080—
+1K080480Nanocomposite Restorative KitDmg USA, Inc.20081—
+1K061906Clearfil Ceramic PrimerKuraray Medical, Inc.20069—
+1K062382Clearfil DC BondKuraray Medical, Inc.20066—
+1K051796Clearfil Tri-S Bond Single DoseKuraray Medical Kurashiki Plant20051—
+2K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited20230—
+2K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseImicryl Dis Malzemeleri Sanayi VE Ticaret AS20210—
+2K183537PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc.20190—
+2K171772Ecosite Bulk FillDmg USA, Inc.20180—
+2K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+2K131432Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Kuraray Noritake Dental, Inc.20131—
+2K091705Primer PlusBisco, Inc.20091—
+2K091300Ascent Porcelain Primer, Model 006-00078, 00600079CAO Group, Inc.20090—
+2K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+3K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.20210—
+3K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG20190—
+3K180802Meta P&BondMeta Biomed Co., Ltd.20180—
+3K171449MetacemMeta Biomed Co., Ltd.20181—
+3K131357PEAK ZUltradent Products, Inc.20130—
+4K261166Dia-CemDiaDent Group International20260—