510(k) Report

Devices descending from K913965

37 later devices reach Espe (R) -Sil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071131UNO3M Espe AG Dental Products200735—
+1K071260Hermes Bond 33M Espe AG Dental Products20070—
+2K110302Adhesive Exl-7593M Espe AG201134—
+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—
+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—
+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—
+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—
+6K240743Peak Universal BondUltradent Products, Inc.20241—
+6K220804Dia-X Bond UniversalDiaDent Group International20220—
+7K262252MPa Max adhesiveDen-Mat Holdings, LLC20260—