510(k) Report

Devices descending from K962785

45 later devices reach 3M Dent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183424Ambar, Ambar APS, Ambar Universal APSDentscare Ltda20190—
+1K181910BracePaste MTP Light Cure PrimerAmerican Orthodontics20180—
+1K172977Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant GelNanova Biomaterials, Inc.20180—
+1K132923Fusion Single LinkAngelus Industria DE Productos Odontologicos SA20140—
+1K110403Prolink Adhesives (Prolink, Prolink SE)Silmet, Ltd.20111—
+1K110302Adhesive Exl-7593M Espe AG201134—
+1K070956SEA2 Self Etch Adhesive3M Espe Dental Products20070—
+1K060684Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products200638—
+2K252151els unibondSaremco Dental AG20250—
+2K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation20250—
+2K241445K-Bond UniversalSpident Co., Ltd.20241—
+2K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited20230—
+2K230009EZ Bond UniversalMeta Biomed Co., Ltd.20230—
+2K222581Stela Automix SystemSdi Limited20221—
+2K222583Stela Capsule SystemSdi Limited20220—
+2K200153Bright Bond UniversalGenoss Co., Ltd.20200—
+2K191656ZipbondSdi Limited20190—
+2K192961ADH193M Deutschland GmbH20192—
+2K181476Prime&Bond active Universal AdhesiveDentsply Sirona20180—
+2K171226Tokuyama Universal BondTokuyama Dental Corporation20171—
+2K172176Parkell Universal AdhesiveParkell, Inc.20170—
+2K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.20165—
+2K133318Adhese UniversalIvoclar Vivadent, AG20142—
+2K112118DreambondBisco, Inc.20118—
+2K071131UNO3M Espe AG Dental Products200735—
+2K071260Hermes Bond 33M Espe AG Dental Products20070—
+3K260682Bond-PR™ Universal AdhesivePremier Dental Products Company20260—
+3K251946G aenial Universal Injectable IIGC America, Inc.20250—
+3K242097DenMat Bulk Fill CompositeDen-Mat Holdings, LLC20240—
+3K222830Rainbow 360Kerr Corporation20230—
+3K210804Adhese Universal DC, Cention PrimerIvoclar Vivadent, AG20221—
+3K203760Tokuyama Universal Bond IITokuyama Dental Corporation20210—
+3K200798G-Cem OneGC America, Inc.20203—
+3K201787Light Cure Dental AdhesiveRizhao Huge Biomaterials Company, Ltd.20200—
+3K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc.20166—
+4K261840BracePaste Prime PlusAmerican Orthodontics20260—
+4K254109G-Cem UniversalGC America, Inc.20260—
+4K252450Adhese 2Ivoclar Vivadent, Inc.20260—
+4K254063iCEM Universal PlusKulzer, LLC20250—
+4K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment…Overfibers S.R.L.20250—
+4K230465Hi-Bond UniversalMediclus Co., Ltd.20232—
+4K213401DIAPLUS UniversalDiaDent Group International20221—
+5K240743Peak Universal BondUltradent Products, Inc.20241—
+5K220804Dia-X Bond UniversalDiaDent Group International20220—
+6K262252MPa Max adhesiveDen-Mat Holdings, LLC20260—