510(k) Report

Devices descending from K083610

64 later devices reach Filtek Supreme Ultra Universal Restorative through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222581Stela Automix SystemSdi Limited20221—
+1K222583Stela Capsule SystemSdi Limited20220—
+1K213339DENU Composite Resin, DENU Flow ResinHdi, Inc.20221—
+1K202063TrusFIL Universal Composite RestorativeRizhao Huge Biomaterials Company, Ltd.20211—
+1K191991EzfilMeta Biomed Co., Ltd.20200—
+1K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona20160—
+1K152004Nanova Universal CompositeNanova Biomaterials, Inc.20150—
+1K151094Mosaic Universal CompositeUltradent Products, Inc.20151—
+1K141081Filtek Bulk Fill Posterior Restroative3M Espe Dental Products20149—
+1K112501Venus Pearl PLT Refill A1Heraeus Kulzer, LLC20111—
+1K110131Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative3M Espe Dental Products2011391
+2K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneKulzer, LLC20260—
+2K242816QuantiumBisco, Inc.20240—
+2K242097DenMat Bulk Fill CompositeDen-Mat Holdings, LLC20240—
+2K240823els extra low shrinkage® composite & els extra low shrinkage® flowSaremco Dental AG20240—
+2K240694FORMA Composite (Shade A3D)Ultradent Products, Inc.20240—
+2K1834763M Filtek Universal Restorative3M Espe Dental Products20195—
+2K171147REVEAL BulkBisco, Inc.20170—
+2K162323Tooth Shade Resin MaterialLiaoning Upcera Co., Ltd.20170—
+2K163207Filtek One Bulk Fill Restorative3M Company20161—
+2K133824CerasmartGC America, Inc.201432—
+2K130654Crystal UltraDental Laboratory Milling Supplies, LLC (Dlms)20130—
+2K122269EnamicVita Zahnfabrik H.Rauter GmbH & Co.20123—
+2K122569Lava Ultimate Cad/Cam Restorative for Cerec Lava Ultimate Cad/Cam Restorative for E4D…3M Company201201
+3K262202Cerasmart ForteGC America, Inc.20260—
+3K243940VITA YZ Multi TranslucentVita Zahnfabrik H.Rauter GmbH & Co.20250—
+3K241147Any-ComMediclus Co., Ltd.20241—
+3K231523EsCom250Spident Co., Ltd.20230—
+3K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation20220—
+3K191306Llis, Vittra APSDentscare Ltda20191—
+3K181500BRILLIANT CriosColtene/Whaledent AG20181—
+3K173573Tetric CADIvoclar Vivadent, AG20180—
+3K163346MAZIC DuroVericom Co., Ltd.20170—
+3K160425CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc.201626—
+3K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+4K250823Any-Com FlowMediclus Co., Ltd.20250—
+4K241131edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir…Edelweiss Dentistry Products GmbH20240—
+4K210231Vittra APS UniqueDentscare Ltda20210—
+4K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc.201625—
+5K201668VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG202024—
+6K233273C&B Ceramic; C&B Permanent; C&B InterimPrevest Denpro Limited20240—
+6K211345C-30 Crown KitPerfect Fit Crowns, LLC20210—
+6K202846Tera HarzGraphy, Inc.202113—
+6K210977E-Dent 1000Envisiontec GmbH20217—
+7K241673Denture Base Resin (PN-Denture (Red, White))Shenzhen Piocreat 3D Technology Co., Ltd.20240—
+7K232559C&B NFH HybridArum Dentistry Co., Ltd.20240—
+7K231142Temporis, Irix PlusDws S.R.L.20240—
+7K233502Tera Harz IIGraphy, Inc.20231—
+7K222623Digital CrownSprintray, Inc.20224—
+7K222877FREEPRINT crownDetax GmbH20222—
+7K220771Stratasys TrueDentStratasys, Ltd.202215
+7K213343Saremco Print CROWNTECSaremco Dental AG20226—
+8K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.20260—
+8K260661Midas RestoreSprintray, Inc.20260—
+8K260170LumiCeraHangzhou SHINING3D Dental Technology Co., Ltd.20260—
+8K250763ReonC.E.I.B.Med20250—
+8K250497Additive Manufacturing (Light Curing) Crown Bridge ResinAidite (Qinhuangdao) Technology Co., Ltd.20250—
+8K242277Crown HTSprintray, Inc.20241—
+8K241071NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V.20240—
+8K232050saremco print BRIDGETECSaremco Dental AG20230—
+8K233596VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG20233—
+9K261246SRGC-06GC America, Inc.20260—
+9K253053Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd.20251—
+10K261356Dura-CrownHangzhou SHINING3D Dental Technology Co., Ltd.20260—