510(k) Report

Devices descending from K012439

63 later devices reach Dentaleye 2 Dental Image Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060178Vix Win ProGendex Dental Systems2006351
+1K053010Vistadent at Complete, Model 3.1Dentsply Intl., Inc.20051—
+1K050744Kavo Ergocom/ErgocamKavo America Corporation200536—
+1K043104Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc.200525—
+2K213263OnyxCephImage Instruments GmbH20230—
+2K141451VixWin PlatinumImaging Sciences International (Dba Gendex, LLC)201414—
+2K131594Ezdenti-I; E2; Prora ViewEwoosoft Co., Ltd.201314—
+2K122427CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC201222—
+2K110886Clio/CliosoftSota Precision Optics, Inc.20111—
+2K111102RadiovisionHaas Software20110—
+2K090431Dexis SoftwareDexis, LLC20090—
+2K070664Progeny Imaging Software, Model# 500-405 (6,7,8).Progeny, Inc.20070—
+3K241495Jazz ClassicJazz Imaging20240—
+3K162799CliniviewPalodex Group OY201713—
+3K150747EzDent-i /E2/Prora ViewLK Consulting Group USA, Inc.201513—
+3K131348OrtomedInfomed Servicios Informaticos S.L.20141—
+3K131570OrthovisionEwoosoft Co., Ltd.201319—
+4K203156DTX Studio ClinicNobel Biocare AB202010—
+4K192165Acteon Imaging SuiteDe Gotzen S.R.L.20200—
+4K172168WillCephHdx Will Corp.20180—
+4K172224DTX Studio diagnoseNobel Biocare AB20180—
+4K173094OrthoVisionEwoosoft Co., Ltd.201718—
+4K161117EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd.201612—
+5K213562DTX Studio Clinic 3.0Nobel Biocare AB20229—
+5K192888EzOrthoEwoosoft Co., Ltd.202017—
+5K163533EzDent-i; E2; ProraViewEwoosoft Co., Ltd.201711—
+6K233925Relu CreatorRelu BV20246—
+6K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+6K220903WebCephAssemblecircle Corp.20222—
+6K210187Overjet Dental AssistOverjet, Inc.20216—
+6K202948EzOrthoEwoosoft Co., Ltd.20206—
+6K172364EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd.201710—
+7K260851Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp.20260—
+7K260785DS Core CBCT AnatomyDentsply Sirona20261—
+7K252538CEPHX3DOrca Dental AI, Ltd.20260—
+7K251514Overjet CBCT AssistOverjet, Inc.20250—
+7K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—
+7K243989Second Opinion® 3DPearl, Inc.20253—
+7K243230Second Opinion® BLEPearl, Inc.20250—
+7K231396CEPHX- Cephalometric Analysis SoftwareOrca Dental AI, Ltd.20241—
+7K232440Adravision PerioAdra Corporation20230—
+7K230144Denti.AI DetectDenti.Ai Technology, Inc.20231—
+7K223296Videa Perio AssistVideahealth, Inc.20230—
+7K211793EzOrthoEwoosoft Co., Ltd.20215—
+7K190087EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd.20199—
+8K262127DS Core CBCT AnatomyDentsply Sirona20260—
+8K254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.20260—
+8K250525Second Opinion® PanoramicPearl, Inc.20250—
+8K243005AudaxCeph Cephalogram Analysis SoftwareAudax D.O.O.20250—
+8K220003EzOrtho v1.3Ewoosoft Co., Ltd.20224—
+8K202116EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd.20208—
+9K222054Denti.AI Auto-ChartDenti.Ai Technology, Inc.20223—
+9K211795EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd.20214—
+9K211700EzDent WebEwoosoft Co., Ltd.20212—
+10K233590Overjet Charting AssistOverjet, Inc.20242—
+10K230468EzDent WebEwoosoft Co., Ltd.20231—
+10K222145EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd.20223—
+11K250716Image OneInfomed Software, S.L.20250—
+11K241684Overjet Charting AssistOverjet, Inc.20241—
+11K223820EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd.20232—
+12K261059Overjet Multi-Image Caries and Charting AssistOverjet, Inc.20260—
+12K241114EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)Ewoosoft Co., Ltd.20241—
+13K250005Clever OneEwoosoft Co., Ltd.20250—