510(k) Report

Devices descending from K942493

125 later devices reach Scotchbond Multi-Purpose Plus Dental Adhesive System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063444Total Etch Bonding AgentDmg USA, Inc.20070—
+1K974486Clearfil Liner Bond 2VKuraray America, Inc.199867—
+1K964525Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl.199786—
+1K9627853M Dent System3M Company199645—
+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—
+2K122522Dentoetch Quickbond Bond ActivatorItena Clinical20130—
+2K110403Prolink Adhesives (Prolink, Prolink SE)Silmet, Ltd.20111—
+2K110302Adhesive Exl-7593M Espe AG201134—
+2K070956SEA2 Self Etch Adhesive3M Espe Dental Products20070—
+2K060684Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products200638—
+2K012440Modification to Clearfil Liner Bond 2VKuraray Medical, Inc.200111—
+2K990040Clearfil SE BondKuraray Co.199964—
+2K982394Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl.199822—
+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—
+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—
+3K070413Ascent Universal Adhesive, Model 006-00028CAO Group, Inc.20071—
+3K063558Peak SE, Model 5135Ultradent Products, Inc.200602
+3K062382Clearfil DC BondKuraray Medical, Inc.20066—
+3K040952PreludeDanville Materials, Inc.20040—
+3K041343Xeno NM Light Cured Dental AdhesiveDentsply International20042—
+3K023842Clearfil SE Bond PlusKuraray Medical, Inc.20033—
+3K023776Xeno Iii Dental AdhesiveDentsply Intl.20033—
+3K013519SimpleBisco, Inc.20020—
+3K012082Optibond Solo Plus ActivatorSybron Dental Specialties, Inc.20011—
+3K012442Modification to Clearfil SE BondKuraray Medical, Inc.200160—
+3K992822Seal & Protect Protective Sealant for Exposed DentineDentsply Intl.19999—
+3K992518Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl.19990—
+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—
+4K183391Novidia Universal BondNobio, Ltd.20190—
+4K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc.20166—
+4K131432Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Kuraray Noritake Dental, Inc.20131—
+4K111975Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKuraray Medical, Inc.20110—
+4K111980Clearfil Tri-S Bond PlusKuraray America, Inc.20114—
+4K092616Ascent Bond Universal Adhesive System, Models 006-00029, 006-00030, 006-00044, 006-00045CAO Group, Inc.20090—
+4K063595Clearfil Majesty PosteriorKuraray America, Inc.20074—
+4K063593Clearfil Majesty FlowKuraray America, Inc.200717—
+4K061906Clearfil Ceramic PrimerKuraray Medical, Inc.20069—
+4K061427Pre-Impression Conditioning SolutionDentsply Intl.20060—
+4K051463Xeno Adhesive with ActivatorDentsply Intl.20051—
+4K042929Estenia C&BKuraray Medical Kurashiki Plant200412—
+4K041960Composite/Compomer Repair KitDmg USA, Inc.20041—
+4K032455Panavia F 2.0Kuraray Medical, Inc.200334—
+4K024356Clearfil Silane KitKuraray Medical, Inc.20034—
+4K022999Clearfil AP-X PLT Intro KitKuraray Medical, Inc.20020—
+4K021805Seal & Protect Protective SealantDentsply Intl.20024—
+4K003482Proclude-SensitiveOrtek Therapeutics, Inc.20013—
+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—
+5K162967nuance UNIVERSALDen-Mat Holdings, LLC20170—
+5K151619Prime&Bond Elect Universal Dental AdhesiveDentsply International, Inc.20150—
+5K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+5K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc.20150—
+5K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc.20154—
+5K133078K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc.20130—
+5K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc.20131—
+5K130371Clearfil Majesty ES FlowKuraray Noritake Dental, Inc.20130—
+5K121583Clearfil Majesty FlowKuraray Noritake Dental, Inc.20123—
+5K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc.20125—
+5K111982Clearfil DC Core PlusKuraray America, Inc.20116—
+5K103461Colgate Desensitizing Dental CreamColgate-Palmolive Co.20112—
+5K110508Suglue-103M Espe AG20118—
+5K100908Unicem HM3M Espe AG Dental Products20101—
+5K100756MALTA3M Espe AG Dental Products201019—
+5K094007Unicem3M Espe AG Dental Products201022—
+5K100328Clearfil Majety PosteriorKuraray Medical, Inc.20100—
+5K091705Primer PlusBisco, Inc.20091—
+5K091300Ascent Porcelain Primer, Model 006-00078, 00600079CAO Group, Inc.20090—
+5K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+5K081583Clearfil SA CementKuraray Medical, Inc.20089—