510(k) Report

Devices descending from K042348

44 later devices reach Gradia Direct Loflo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091388GCUC-505GC America, Inc.200943—
+2K200155Bright High FlowGenoss Co., Ltd.20200—
+2K200156Bright Low FlowGenoss Co., Ltd.20200—
+2K173500NMF004AGC America, Inc.20182—
+2K140976Enaden FlowKm Corporation20140—
+2K133182HTFX-222GC America, Inc.20140—
+2K123631MFP-051GC America, Inc.201339—
+3K251946G aenial Universal Injectable IIGC America, Inc.20250—
+3K250317EsFlow PLUSSpident Co., Ltd.20250—
+3K153325Gradia PlusGC America, Inc.20160—
+3K141562MSN-006GC America, Inc.20140—
+3K133824CerasmartGC America, Inc.201432—
+4K262202Cerasmart ForteGC America, Inc.20260—
+4K181500BRILLIANT CriosColtene/Whaledent AG20181—
+4K173573Tetric CADIvoclar Vivadent, AG20180—
+4K163346MAZIC DuroVericom Co., Ltd.20170—
+4K160425CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc.201626—
+5K241131edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir…Edelweiss Dentistry Products GmbH20240—
+5K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc.201625—
+6K201668VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG202024—
+7K233273C&B Ceramic; C&B Permanent; C&B InterimPrevest Denpro Limited20240—
+7K211345C-30 Crown KitPerfect Fit Crowns, LLC20210—
+7K202846Tera HarzGraphy, Inc.202113—
+7K210977E-Dent 1000Envisiontec GmbH20217—
+8K241673Denture Base Resin (PN-Denture (Red, White))Shenzhen Piocreat 3D Technology Co., Ltd.20240—
+8K232559C&B NFH HybridArum Dentistry Co., Ltd.20240—
+8K231142Temporis, Irix PlusDws S.R.L.20240—
+8K233502Tera Harz IIGraphy, Inc.20231—
+8K222623Digital CrownSprintray, Inc.20224—
+8K222877FREEPRINT crownDetax GmbH20222—
+8K220771Stratasys TrueDentStratasys, Ltd.202215
+8K213343Saremco Print CROWNTECSaremco Dental AG20226—
+9K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.20260—
+9K260661Midas RestoreSprintray, Inc.20260—
+9K260170LumiCeraHangzhou SHINING3D Dental Technology Co., Ltd.20260—
+9K250763ReonC.E.I.B.Med20250—
+9K250497Additive Manufacturing (Light Curing) Crown Bridge ResinAidite (Qinhuangdao) Technology Co., Ltd.20250—
+9K242277Crown HTSprintray, Inc.20241—
+9K241071NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V.20240—
+9K232050saremco print BRIDGETECSaremco Dental AG20230—
+9K233596VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG20233—
+10K261246SRGC-06GC America, Inc.20260—
+10K253053Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd.20251—
+11K261356Dura-CrownHangzhou SHINING3D Dental Technology Co., Ltd.20260—