510(k) Report

Devices descending from K941572

90 later devices reach Fluoride-Psa Prime/Adhesive through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962348Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl.199689—
+2K983414EverbondEspe Dental AG19980—
+2K982692Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LCSterngold/Implamed19980—
+2K982394Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl.199822—
+2K964525Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl.199786—
+3K122522Dentoetch Quickbond Bond ActivatorItena Clinical20130—
+3K070413Ascent Universal Adhesive, Model 006-00028CAO Group, Inc.20071—
+3K041343Xeno NM Light Cured Dental AdhesiveDentsply International20042—
+3K023842Clearfil SE Bond PlusKuraray Medical, Inc.20033—
+3K023776Xeno Iii Dental AdhesiveDentsply Intl.20033—
+3K012082Optibond Solo Plus ActivatorSybron Dental Specialties, Inc.20011—
+3K992822Seal & Protect Protective Sealant for Exposed DentineDentsply Intl.19999—
+3K992518Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl.19990—
+3K990040Clearfil SE BondKuraray Co.199964—
+3K974486Clearfil Liner Bond 2VKuraray America, Inc.199867—
+4K183391Novidia Universal BondNobio, Ltd.20190—
+4K092616Ascent Bond Universal Adhesive System, Models 006-00029, 006-00030, 006-00044, 006-00045CAO Group, Inc.20090—
+4K070956SEA2 Self Etch Adhesive3M Espe Dental Products20070—
+4K063558Peak SE, Model 5135Ultradent Products, Inc.200602
+4K061427Pre-Impression Conditioning SolutionDentsply Intl.20060—
+4K051463Xeno Adhesive with ActivatorDentsply Intl.20051—
+4K041960Composite/Compomer Repair KitDmg USA, Inc.20041—
+4K040952PreludeDanville Materials, Inc.20040—
+4K021805Seal & Protect Protective SealantDentsply Intl.20024—
+4K013519SimpleBisco, Inc.20020—
+4K012442Modification to Clearfil SE BondKuraray Medical, Inc.200160—
+4K012440Modification to Clearfil Liner Bond 2VKuraray Medical, Inc.200111—
+4K003482Proclude-SensitiveOrtek Therapeutics, Inc.20013—
+5K151619Prime&Bond Elect Universal Dental AdhesiveDentsply International, Inc.20150—
+5K131432Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Kuraray Noritake Dental, Inc.20131—
+5K103461Colgate Desensitizing Dental CreamColgate-Palmolive Co.20112—
+5K063444Total Etch Bonding AgentDmg USA, Inc.20070—
+5K063595Clearfil Majesty PosteriorKuraray America, Inc.20074—
+5K063593Clearfil Majesty FlowKuraray America, Inc.200717—
+5K061906Clearfil Ceramic PrimerKuraray Medical, Inc.20069—
+5K062382Clearfil DC BondKuraray Medical, Inc.20066—
+5K042929Estenia C&BKuraray Medical Kurashiki Plant200412—
+5K032455Panavia F 2.0Kuraray Medical, Inc.200334—
+5K024356Clearfil Silane KitKuraray Medical, Inc.20034—
+5K022999Clearfil AP-X PLT Intro KitKuraray Medical, Inc.20020—
+6K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited20230—
+6K162967nuance UNIVERSALDen-Mat Holdings, LLC20170—
+6K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+6K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc.20150—
+6K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc.20154—
+6K140481Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief MouthwashColgate-Palmolive Company20141—
+6K133078K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc.20130—
+6K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc.20131—
+6K130371Clearfil Majesty ES FlowKuraray Noritake Dental, Inc.20130—
+6K121583Clearfil Majesty FlowKuraray Noritake Dental, Inc.20123—
+6K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc.20125—
+6K111982Clearfil DC Core PlusKuraray America, Inc.20116—
+6K111975Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKuraray Medical, Inc.20110—
+6K111980Clearfil Tri-S Bond PlusKuraray America, Inc.20114—
+6K110508Suglue-103M Espe AG20118—
+6K100908Unicem HM3M Espe AG Dental Products20101—
+6K100756MALTA3M Espe AG Dental Products201019—
+6K094007Unicem3M Espe AG Dental Products201022—
+6K100328Clearfil Majety PosteriorKuraray Medical, Inc.20100—
+6K091705Primer PlusBisco, Inc.20091—
+6K091300Ascent Porcelain Primer, Model 006-00078, 00600079CAO Group, Inc.20090—
+6K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+6K081583Clearfil SA CementKuraray Medical, Inc.20089—
+6K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc.20071—
+6K063228Surface CoatKuraray America, Inc.20060—
+6K062410Clearfil Esthetic Cement & DC BondKuraray Medical, Inc.200610—
+7K252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao Huge Biomaterials Company, Ltd.20250—
+7K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.20210—
+7K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseImicryl Dis Malzemeleri Sanayi VE Ticaret AS20210—
+7K192992Suglue 33M Deutschland GmbH20190—
+7K183465Allcem, Allcem CoreDentscare Ltda20190—
+7K191548Nexus Universal Self-CureKerr Corporation201901
+7K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG20190—
+7K182430Clearfil Majesty ICKuraray Noritake Dental, Inc.20190—
+7K183537PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc.20190—
+7K180802Meta P&BondMeta Biomed Co., Ltd.20180—
+7K171449MetacemMeta Biomed Co., Ltd.20181—
+7K170873Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi…Swissmeditec GmbH20170—
+7K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.20165—
+7K152691EDS Universal CementEssential Dental Systems, Inc.20160—
+7K143155LISTERINE Sensitivity Defense MouthrinseJohnson & Johnson Healthcare Products, Division of Mcneil-Pp20150—
+7K131357PEAK ZUltradent Products, Inc.20130—
+7K120378Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix…Kuraray Medical, Inc.20121—
+7K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc.20090—
+8K261166Dia-CemDiaDent Group International20260—
+8K251946G aenial Universal Injectable IIGC America, Inc.20250—
+8K200798G-Cem OneGC America, Inc.20203—
+9K254109G-Cem UniversalGC America, Inc.20260—
+9K254063iCEM Universal PlusKulzer, LLC20250—
+9K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment…Overfibers S.R.L.20250—