510(k) Report

Devices descending from K012440

11 later devices reach Modification to Clearfil Liner Bond 2V through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062382Clearfil DC BondKuraray Medical, Inc.20066—
+1K023842Clearfil SE Bond PlusKuraray Medical, Inc.20033—
+2K183391Novidia Universal BondNobio, Ltd.20190—
+2K131432Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Kuraray Noritake Dental, Inc.20131—
+2K122522Dentoetch Quickbond Bond ActivatorItena Clinical20130—
+2K111975Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKuraray Medical, Inc.20110—
+2K111980Clearfil Tri-S Bond PlusKuraray America, Inc.20114—
+2K070956SEA2 Self Etch Adhesive3M Espe Dental Products20070—
+3K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited20230—
+3K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc.20131—
+4K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseImicryl Dis Malzemeleri Sanayi VE Ticaret AS20210—