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
+1K9627853M Dent System3M Company199645—
+1K960823Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl.199690—
+2K183424Ambar, Ambar APS, Ambar Universal APSDentscare Ltda20190—
+2K181910BracePaste MTP Light Cure PrimerAmerican Orthodontics20180—
+2K172977Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant GelNanova Biomaterials, Inc.20180—
+2K132923Fusion Single LinkAngelus Industria DE Productos Odontologicos SA20140—
+2K110403Prolink Adhesives (Prolink, Prolink SE)Silmet, Ltd.20111—
+2K110302Adhesive Exl-7593M Espe AG201134—
+2K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+2K070956SEA2 Self Etch Adhesive3M Espe Dental Products20070—
+2K060684Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products200638—
+2K962348Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl.199689—
+3K252151els unibondSaremco Dental AG20250—
+3K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation20250—
+3K241445K-Bond UniversalSpident Co., Ltd.20241—
+3K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited20230—
+3K230009EZ Bond UniversalMeta Biomed Co., Ltd.20230—
+3K222581Stela Automix SystemSdi Limited20221—
+3K222583Stela Capsule SystemSdi Limited20220—
+3K200153Bright Bond UniversalGenoss Co., Ltd.20200—
+3K191656ZipbondSdi Limited20190—
+3K192961ADH193M Deutschland GmbH20192—
+3K181476Prime&Bond active Universal AdhesiveDentsply Sirona20180—
+3K180802Meta P&BondMeta Biomed Co., Ltd.20180—
+3K171449MetacemMeta Biomed Co., Ltd.20181—
+3K171226Tokuyama Universal BondTokuyama Dental Corporation20171—
+3K172176Parkell Universal AdhesiveParkell, Inc.20170—
+3K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.20165—
+3K133318Adhese UniversalIvoclar Vivadent, AG20142—
+3K112118DreambondBisco, Inc.20118—
+3K071131UNO3M Espe AG Dental Products200735—
+3K071260Hermes Bond 33M Espe AG Dental Products20070—
+3K983414EverbondEspe Dental AG19980—
+3K982692Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LCSterngold/Implamed19980—
+3K982394Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl.199822—
+3K964525Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl.199786—
+4K261166Dia-CemDiaDent Group International20260—
+4K260682Bond-PR™ Universal AdhesivePremier Dental Products Company20260—
+4K251946G aenial Universal Injectable IIGC America, Inc.20250—
+4K242097DenMat Bulk Fill CompositeDen-Mat Holdings, LLC20240—
+4K222830Rainbow 360Kerr Corporation20230—
+4K210804Adhese Universal DC, Cention PrimerIvoclar Vivadent, AG20221—
+4K203760Tokuyama Universal Bond IITokuyama Dental Corporation20210—
+4K200798G-Cem OneGC America, Inc.20203—
+4K201787Light Cure Dental AdhesiveRizhao Huge Biomaterials Company, Ltd.20200—
+4K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc.20166—
+4K122522Dentoetch Quickbond Bond ActivatorItena Clinical20130—
+4K070413Ascent Universal Adhesive, Model 006-00028CAO Group, Inc.20071—
+4K041343Xeno NM Light Cured Dental AdhesiveDentsply International20042—
+4K023842Clearfil SE Bond PlusKuraray Medical, Inc.20033—
+4K023776Xeno Iii Dental AdhesiveDentsply Intl.20033—
+4K012082Optibond Solo Plus ActivatorSybron Dental Specialties, Inc.20011—
+4K992822Seal & Protect Protective Sealant for Exposed DentineDentsply Intl.19999—
+4K992518Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl.19990—
+4K990040Clearfil SE BondKuraray Co.199964—
+4K974486Clearfil Liner Bond 2VKuraray America, Inc.199867—
+5K261840BracePaste Prime PlusAmerican Orthodontics20260—
+5K254109G-Cem UniversalGC America, Inc.20260—
+5K252450Adhese 2Ivoclar Vivadent, Inc.20260—
+5K254063iCEM Universal PlusKulzer, LLC20250—
+5K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment…Overfibers S.R.L.20250—
+5K230465Hi-Bond UniversalMediclus Co., Ltd.20232—
+5K213401DIAPLUS UniversalDiaDent Group International20221—
+5K183391Novidia Universal BondNobio, Ltd.20190—
+5K092616Ascent Bond Universal Adhesive System, Models 006-00029, 006-00030, 006-00044, 006-00045CAO Group, Inc.20090—
+5K063558Peak SE, Model 5135Ultradent Products, Inc.200602
+5K061427Pre-Impression Conditioning SolutionDentsply Intl.20060—
+5K051463Xeno Adhesive with ActivatorDentsply Intl.20051—
+5K041960Composite/Compomer Repair KitDmg USA, Inc.20041—
+5K040952PreludeDanville Materials, Inc.20040—
+5K021805Seal & Protect Protective SealantDentsply Intl.20024—
+5K013519SimpleBisco, Inc.20020—
+5K012442Modification to Clearfil SE BondKuraray Medical, Inc.200160—
+5K012440Modification to Clearfil Liner Bond 2VKuraray Medical, Inc.200111—
+5K003482Proclude-SensitiveOrtek Therapeutics, Inc.20013—
+6K240743Peak Universal BondUltradent Products, Inc.20241—
+6K220804Dia-X Bond UniversalDiaDent Group International20220—
+6K151619Prime&Bond Elect Universal Dental AdhesiveDentsply International, Inc.20150—
+6K131432Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Kuraray Noritake Dental, Inc.20131—
+6K103461Colgate Desensitizing Dental CreamColgate-Palmolive Co.20112—
+6K063444Total Etch Bonding AgentDmg USA, Inc.20070—
+6K063595Clearfil Majesty PosteriorKuraray America, Inc.20074—
+6K063593Clearfil Majesty FlowKuraray America, Inc.200717—
+6K061906Clearfil Ceramic PrimerKuraray Medical, Inc.20069—
+6K062382Clearfil DC BondKuraray Medical, Inc.20066—
+6K042929Estenia C&BKuraray Medical Kurashiki Plant200412—
+6K032455Panavia F 2.0Kuraray Medical, Inc.200334—
+6K024356Clearfil Silane KitKuraray Medical, Inc.20034—
+6K022999Clearfil AP-X PLT Intro KitKuraray Medical, Inc.20020—
+7K262252MPa Max adhesiveDen-Mat Holdings, LLC20260—
+7K162967nuance UNIVERSALDen-Mat Holdings, LLC20170—
+7K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+7K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc.20150—
+7K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc.20154—
+7K140481Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief MouthwashColgate-Palmolive Company20141—
+7K133078K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc.20130—
+7K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc.20131—
+7K130371Clearfil Majesty ES FlowKuraray Noritake Dental, Inc.20130—
+7K121583Clearfil Majesty FlowKuraray Noritake Dental, Inc.20123—
+7K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc.20125—