510(k) Report

Devices descending from K962440

90 later devices reach Pertac II/Pertac II Aplitip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033996Hermes3M Espe AG Dental Products20040—
+1K992966ReferenceEspe Dental AG19991—
+1K992645SinfonyEspe Dental AG199959—
+1K983414EverbondEspe Dental AG19980—
+1K974458Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg.199870—
+2K152373VITA VM LC FlowVita Zahnfabrik H.Rauter GmbH & Co.20153—
+2K073296TEMPXN283M Espe AG Dental Products20084—
+2K071131UNO3M Espe AG Dental Products200735—
+2K071260Hermes Bond 33M Espe AG Dental Products20070—
+2K042929Estenia C&BKuraray Medical Kurashiki Plant200412—
+2K020256Unicem3M Espe AG Dental Products200263—
+2K993566PromptflowEspe Dental AG19990—
+2K984246Prompt L-PopEspe Dental AG19995—
+3K240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…Kulzer, LLC20241—
+3K230644Signum opaque FKulzer, LLC20230—
+3K202965CURA-TempMgnewton, Ltd.20220—
+3K210945Ultra SEPReliance Orthodontic Products, Inc.20210—
+3K151144SuPro 1003M Deutschland GmbH20150—
+3K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+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—
+3K111982Clearfil DC Core PlusKuraray America, Inc.20116—
+3K110302Adhesive Exl-7593M Espe AG201134—
+3K100908Unicem HM3M Espe AG Dental Products20101—
+3K100756MALTA3M Espe AG Dental Products201019—
+3K073173Self-Adhesive Resin CementDentsply Interntional20086—
+3K071688Reliance S.E.P.Reliance Orthodontic Products, Inc.20070—
+3K063595Clearfil Majesty PosteriorKuraray America, Inc.20074—
+3K043043Hermes Bond 23M Espe AG Dental Products200537—
+3K033974Hermes Bond3M Espe AG Dental Products20040—
+3K031494Doc's Best White Copper CementCooley & Cooley, Ltd.20030—
+3K992048Modification of Prompt L-PopEspe Dental AG199901
+4K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.20260—
+4K252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao Huge Biomaterials Company, Ltd.20250—
+4K252151els unibondSaremco Dental AG20250—
+4K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation20250—
+4K241445K-Bond UniversalSpident Co., Ltd.20241—
+4K230009EZ Bond UniversalMeta Biomed Co., Ltd.20230—
+4K222581Stela Automix SystemSdi Limited20221—
+4K222583Stela Capsule SystemSdi Limited20220—
+4K210259Parkell Self-Adhesive CementParkell, Inc.20221—
+4K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.20210—
+4K200153Bright Bond UniversalGenoss Co., Ltd.20200—
+4K191656ZipbondSdi Limited20190—
+4K192992Suglue 33M Deutschland GmbH20190—
+4K192961ADH193M Deutschland GmbH20192—
+4K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG20190—
+4K181476Prime&Bond active Universal AdhesiveDentsply Sirona20180—
+4K171226Tokuyama Universal BondTokuyama Dental Corporation20171—
+4K172176Parkell Universal AdhesiveParkell, Inc.20170—
+4K162967nuance UNIVERSALDen-Mat Holdings, LLC20170—
+4K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.20165—
+4K152691EDS Universal CementEssential Dental Systems, Inc.20160—
+4K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc.20150—
+4K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc.20154—
+4K133318Adhese UniversalIvoclar Vivadent, AG20142—
+4K120378Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix…Kuraray Medical, Inc.20121—
+4K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc.20125—
+4K112118DreambondBisco, Inc.20118—
+4K110508Suglue-103M Espe AG20118—
+4K100328Clearfil Majety PosteriorKuraray Medical, Inc.20100—
+4K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+4K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc.20071—
+5K253337REGEN Bioactive CementInter-Med, Inc.20260—
+5K260682Bond-PR™ Universal AdhesivePremier Dental Products Company20260—
+5K251946G aenial Universal Injectable IIGC America, Inc.20250—
+5K242097DenMat Bulk Fill CompositeDen-Mat Holdings, LLC20240—
+5K222830Rainbow 360Kerr Corporation20230—
+5K210804Adhese Universal DC, Cention PrimerIvoclar Vivadent, AG20221—
+5K203760Tokuyama Universal Bond IITokuyama Dental Corporation20210—
+5K200798G-Cem OneGC America, Inc.20203—
+5K201787Light Cure Dental AdhesiveRizhao Huge Biomaterials Company, Ltd.20200—
+5K183465Allcem, Allcem CoreDentscare Ltda20190—
+5K191548Nexus Universal Self-CureKerr Corporation201901
+5K183537PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc.20190—
+5K180802Meta P&BondMeta Biomed Co., Ltd.20180—
+5K171449MetacemMeta Biomed Co., Ltd.20181—
+5K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc.20166—
+5K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc.20090—
+6K261166Dia-CemDiaDent Group International20260—
+6K261840BracePaste Prime PlusAmerican Orthodontics20260—
+6K254109G-Cem UniversalGC America, Inc.20260—
+6K252450Adhese 2Ivoclar Vivadent, Inc.20260—
+6K254063iCEM Universal PlusKulzer, LLC20250—
+6K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment…Overfibers S.R.L.20250—
+6K230465Hi-Bond UniversalMediclus Co., Ltd.20232—
+6K213401DIAPLUS UniversalDiaDent Group International20221—
+7K240743Peak Universal BondUltradent Products, Inc.20241—
+7K220804Dia-X Bond UniversalDiaDent Group International20220—
+8K262252MPa Max adhesiveDen-Mat Holdings, LLC20260—