510(k) Report

Devices descending from K042819

72 later devices reach Tetric Evoceram through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240112Light Cure CompositeSincera Technology (Changchun) Co., Ltd.20240—
+1K2216953M Filtek Supreme Flowable Restorative3M Company Espe Dental Products20221—
+1K201707Opallis, Opallis FlowDentscare Ltda20202—
+1K192178R&D Series Nova Compo NImicryl Dis Malzemeleri Sanayi VE Ticaret AS20190—
+1K182921Infinix Universal CompositeNobio, Ltd.20192—
+1K182780XP CompositeS&C Polymer Silicon- Und Composite Spezialitaeten GmbH20190—
+1K153191Calcium BridgeDenali Corporation20160—
+1K140976Enaden FlowKm Corporation20140—
+1K133182HTFX-222GC America, Inc.20140—
+1K131753MeridianAb Ardent20130—
+1K123631MFP-051GC America, Inc.201339—
+1K091388GCUC-505GC America, Inc.200943—
+1K070583Nano CompositeCosmedent, Inc.20073—
+1K061860Clearfil Majesty EstheticKuraray Medical, Inc.200611—
+2K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.20260—
+2K232994Vittra APS Unique FlowDentscare Ltda20240—
+2K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTPrevest Denpro Limited20240—
+2K200155Bright High FlowGenoss Co., Ltd.20200—
+2K200156Bright Low FlowGenoss Co., Ltd.20200—
+2K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeNobio, Ltd.20201—
+2K173500NMF004AGC America, Inc.20182—
+2K163480Renamel NANO +plusCosmedent, Inc.20170—
+2K153325Gradia PlusGC America, Inc.20160—
+2K141562MSN-006GC America, Inc.20140—
+2K133824CerasmartGC America, Inc.201432—
+2K121583Clearfil Majesty FlowKuraray Noritake Dental, Inc.20123—
+2K080305Nexcomp and Meta EtchantMeta Biomed Co., Ltd.20081—
+2K070325Clearfil Majesty Esthetic PLTKuraray Medical, Inc.20070—
+2K063595Clearfil Majesty PosteriorKuraray America, Inc.20074—
+3K262202Cerasmart ForteGC America, Inc.20260—
+3K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company20250—
+3K251946G aenial Universal Injectable IIGC America, Inc.20250—
+3K250317EsFlow PLUSSpident Co., Ltd.20250—
+3K182430Clearfil Majesty ICKuraray Noritake Dental, Inc.20190—
+3K181689NexcompMeta Biomed Co., Ltd.20180—
+3K181500BRILLIANT CriosColtene/Whaledent AG20181—
+3K173573Tetric CADIvoclar Vivadent, AG20180—
+3K170873Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi…Swissmeditec GmbH20170—
+3K162967nuance UNIVERSALDen-Mat Holdings, LLC20170—
+3K163346MAZIC DuroVericom Co., Ltd.20170—
+3K160425CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc.201626—
+3K130371Clearfil Majesty ES FlowKuraray Noritake Dental, Inc.20130—
+3K100328Clearfil Majety PosteriorKuraray Medical, Inc.20100—
+3K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc.20071—
+4K241131edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir…Edelweiss Dentistry Products GmbH20240—
+4K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc.201625—
+4K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc.20090—
+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—