510(k) Report

Devices descending from K110302

34 later devices reach Adhesive Exl-759 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252151els unibondSaremco Dental AG20250—
+1K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation20250—
+1K241445K-Bond UniversalSpident Co., Ltd.20241—
+1K230009EZ Bond UniversalMeta Biomed Co., Ltd.20230—
+1K222581Stela Automix SystemSdi Limited20221—
+1K222583Stela Capsule SystemSdi Limited20220—
+1K200153Bright Bond UniversalGenoss Co., Ltd.20200—
+1K191656ZipbondSdi Limited20190—
+1K192961ADH193M Deutschland GmbH20192—
+1K181476Prime&Bond active Universal AdhesiveDentsply Sirona20180—
+1K171226Tokuyama Universal BondTokuyama Dental Corporation20171—
+1K172176Parkell Universal AdhesiveParkell, Inc.20170—
+1K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.20165—
+1K133318Adhese UniversalIvoclar Vivadent, AG20142—
+1K112118DreambondBisco, Inc.20118—
+2K260682Bond-PR™ Universal AdhesivePremier Dental Products Company20260—
+2K251946G aenial Universal Injectable IIGC America, Inc.20250—
+2K242097DenMat Bulk Fill CompositeDen-Mat Holdings, LLC20240—
+2K222830Rainbow 360Kerr Corporation20230—
+2K210804Adhese Universal DC, Cention PrimerIvoclar Vivadent, AG20221—
+2K203760Tokuyama Universal Bond IITokuyama Dental Corporation20210—
+2K200798G-Cem OneGC America, Inc.20203—
+2K201787Light Cure Dental AdhesiveRizhao Huge Biomaterials Company, Ltd.20200—
+2K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc.20166—
+3K261840BracePaste Prime PlusAmerican Orthodontics20260—
+3K254109G-Cem UniversalGC America, Inc.20260—
+3K252450Adhese 2Ivoclar Vivadent, Inc.20260—
+3K254063iCEM Universal PlusKulzer, LLC20250—
+3K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment…Overfibers S.R.L.20250—
+3K230465Hi-Bond UniversalMediclus Co., Ltd.20232—
+3K213401DIAPLUS UniversalDiaDent Group International20221—
+4K240743Peak Universal BondUltradent Products, Inc.20241—
+4K220804Dia-X Bond UniversalDiaDent Group International20220—
+5K262252MPa Max adhesiveDen-Mat Holdings, LLC20260—