510(k) Report

Devices descending from K992645

59 later devices reach Sinfony through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152373VITA VM LC FlowVita Zahnfabrik H.Rauter GmbH & Co.20153—
+1K073296TEMPXN283M Espe AG Dental Products20084—
+1K071131UNO3M Espe AG Dental Products200735—
+1K071260Hermes Bond 33M Espe AG Dental Products20070—
+1K042929Estenia C&BKuraray Medical Kurashiki Plant200412—
+2K240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…Kulzer, LLC20241—
+2K230644Signum opaque FKulzer, LLC20230—
+2K202965CURA-TempMgnewton, Ltd.20220—
+2K151144SuPro 1003M Deutschland GmbH20150—
+2K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+2K141562MSN-006GC America, Inc.20140—
+2K122039Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross BKettenbach GmbH & Co. KG20120—
+2K111982Clearfil DC Core PlusKuraray America, Inc.20116—
+2K110302Adhesive Exl-7593M Espe AG201134—
+2K063595Clearfil Majesty PosteriorKuraray America, Inc.20074—
+3K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.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—
+3K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.20210—
+3K200153Bright Bond UniversalGenoss Co., Ltd.20200—
+3K191656ZipbondSdi Limited20190—
+3K192961ADH193M Deutschland GmbH20192—
+3K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG20190—
+3K181476Prime&Bond active Universal AdhesiveDentsply Sirona20180—
+3K171226Tokuyama Universal BondTokuyama Dental Corporation20171—
+3K172176Parkell Universal AdhesiveParkell, Inc.20170—
+3K162967nuance UNIVERSALDen-Mat Holdings, LLC20170—
+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—
+3K100328Clearfil Majety PosteriorKuraray Medical, Inc.20100—
+3K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc.20071—
+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—
+4K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc.20090—
+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—