510(k) Report

Devices descending from K001114

47 later devices reach 3M Quik Temp Temporization Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033022Protemp 3 Garant3M Espe AG Dental Products200346—
+2K073296TEMPXN283M Espe AG Dental Products20084—
+2K061530MD-TempMeta Biomed Co., Ltd.20061—
+2K043043Hermes Bond 23M Espe AG Dental Products200537—
+2K033974Hermes Bond3M Espe AG Dental Products20040—
+3K202965CURA-TempMgnewton, Ltd.20220—
+3K190724MD-Temp PlusMeta Biomed Co., Ltd.20190—
+3K151144SuPro 1003M Deutschland GmbH20150—
+3K141562MSN-006GC America, Inc.20140—
+3K122039Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross BKettenbach GmbH & Co. KG20120—
+3K071131UNO3M Espe AG Dental Products200735—
+3K071260Hermes Bond 33M Espe AG Dental Products20070—
+4K110302Adhesive Exl-7593M Espe AG201134—
+5K252151els unibondSaremco Dental AG20250—
+5K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation20250—
+5K241445K-Bond UniversalSpident Co., Ltd.20241—
+5K230009EZ Bond UniversalMeta Biomed Co., Ltd.20230—
+5K222581Stela Automix SystemSdi Limited20221—
+5K222583Stela Capsule SystemSdi Limited20220—
+5K200153Bright Bond UniversalGenoss Co., Ltd.20200—
+5K191656ZipbondSdi Limited20190—
+5K192961ADH193M Deutschland GmbH20192—
+5K181476Prime&Bond active Universal AdhesiveDentsply Sirona20180—
+5K171226Tokuyama Universal BondTokuyama Dental Corporation20171—
+5K172176Parkell Universal AdhesiveParkell, Inc.20170—
+5K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.20165—
+5K133318Adhese UniversalIvoclar Vivadent, AG20142—
+5K112118DreambondBisco, Inc.20118—
+6K260682Bond-PR™ Universal AdhesivePremier Dental Products Company20260—
+6K251946G aenial Universal Injectable IIGC America, Inc.20250—
+6K242097DenMat Bulk Fill CompositeDen-Mat Holdings, LLC20240—
+6K222830Rainbow 360Kerr Corporation20230—
+6K210804Adhese Universal DC, Cention PrimerIvoclar Vivadent, AG20221—
+6K203760Tokuyama Universal Bond IITokuyama Dental Corporation20210—
+6K200798G-Cem OneGC America, Inc.20203—
+6K201787Light Cure Dental AdhesiveRizhao Huge Biomaterials Company, Ltd.20200—
+6K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc.20166—
+7K261840BracePaste Prime PlusAmerican Orthodontics20260—
+7K254109G-Cem UniversalGC America, Inc.20260—
+7K252450Adhese 2Ivoclar Vivadent, Inc.20260—
+7K254063iCEM Universal PlusKulzer, LLC20250—
+7K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment…Overfibers S.R.L.20250—
+7K230465Hi-Bond UniversalMediclus Co., Ltd.20232—
+7K213401DIAPLUS UniversalDiaDent Group International20221—
+8K240743Peak Universal BondUltradent Products, Inc.20241—
+8K220804Dia-X Bond UniversalDiaDent Group International20220—
+9K262252MPa Max adhesiveDen-Mat Holdings, LLC20260—