510(k) Report

Devices descending from K020256

63 later devices reach Unicem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100908Unicem HM3M Espe AG Dental Products20101—
+1K100756MALTA3M Espe AG Dental Products201019—
+1K073173Self-Adhesive Resin CementDentsply Interntional20086—
+1K071131UNO3M Espe AG Dental Products200735—
+1K071260Hermes Bond 33M Espe AG Dental Products20070—
+1K043043Hermes Bond 23M Espe AG Dental Products200537—
+1K033974Hermes Bond3M Espe AG Dental Products20040—
+1K031494Doc's Best White Copper CementCooley & Cooley, Ltd.20030—
+2K252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao Huge Biomaterials Company, Ltd.20250—
+2K210259Parkell Self-Adhesive CementParkell, Inc.20221—
+2K192992Suglue 33M Deutschland GmbH20190—
+2K152691EDS Universal CementEssential Dental Systems, Inc.20160—
+2K120378Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix…Kuraray Medical, Inc.20121—
+2K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc.20125—
+2K110508Suglue-103M Espe AG20118—
+2K110302Adhesive Exl-7593M Espe AG201134—
+2K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+3K253337REGEN Bioactive CementInter-Med, Inc.20260—
+3K252151els unibondSaremco Dental AG20250—
+3K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation20250—
+3K241445K-Bond UniversalSpident Co., Ltd.20241—
+3K230009EZ Bond UniversalMeta Biomed Co., Ltd.20230—
+3K222581Stela Automix SystemSdi Limited20221—
+3K222583Stela Capsule SystemSdi Limited20220—
+3K200153Bright Bond UniversalGenoss Co., Ltd.20200—
+3K191656ZipbondSdi Limited20190—
+3K183465Allcem, Allcem CoreDentscare Ltda20190—
+3K192961ADH193M Deutschland GmbH20192—
+3K191548Nexus Universal Self-CureKerr Corporation201901
+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—
+3K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc.20150—
+3K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc.20154—
+3K133318Adhese UniversalIvoclar Vivadent, AG20142—
+3K112118DreambondBisco, Inc.20118—
+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—
+4K183537PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc.20190—
+4K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc.20166—
+4K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+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—
+5K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.20210—
+5K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG20190—
+6K240743Peak Universal BondUltradent Products, Inc.20241—
+6K220804Dia-X Bond UniversalDiaDent Group International20220—
+7K262252MPa Max adhesiveDen-Mat Holdings, LLC20260—