510(k) Report

Devices descending from K951864

129 later devices reach Prime & Bond Direct Composite Bonding Agent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K111982Clearfil DC Core PlusKuraray America, Inc.20116—
+7K111975Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKuraray Medical, Inc.20110—
+7K111980Clearfil Tri-S Bond PlusKuraray America, Inc.20114—
+7K110508Suglue-103M Espe AG20118—
+7K100908Unicem HM3M Espe AG Dental Products20101—
+7K100756MALTA3M Espe AG Dental Products201019—
+7K094007Unicem3M Espe AG Dental Products201022—
+7K100328Clearfil Majety PosteriorKuraray Medical, Inc.20100—
+7K091705Primer PlusBisco, Inc.20091—
+7K091300Ascent Porcelain Primer, Model 006-00078, 00600079CAO Group, Inc.20090—
+7K081583Clearfil SA CementKuraray Medical, Inc.20089—
+7K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc.20071—
+7K063228Surface CoatKuraray America, Inc.20060—
+7K062410Clearfil Esthetic Cement & DC BondKuraray Medical, Inc.200610—
+8K252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao Huge Biomaterials Company, Ltd.20250—
+8K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.20210—
+8K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseImicryl Dis Malzemeleri Sanayi VE Ticaret AS20210—
+8K192992Suglue 33M Deutschland GmbH20190—
+8K183465Allcem, Allcem CoreDentscare Ltda20190—
+8K191548Nexus Universal Self-CureKerr Corporation201901
+8K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG20190—
+8K182430Clearfil Majesty ICKuraray Noritake Dental, Inc.20190—
+8K183537PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc.20190—
+8K170873Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi…Swissmeditec GmbH20170—
+8K152691EDS Universal CementEssential Dental Systems, Inc.20160—
+8K143155LISTERINE Sensitivity Defense MouthrinseJohnson & Johnson Healthcare Products, Division of Mcneil-Pp20150—
+8K131357PEAK ZUltradent Products, Inc.20130—
+8K120378Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix…Kuraray Medical, Inc.20121—
+8K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc.20090—