510(k) Report

Devices descending from K043104

25 later devices reach Kodak Orthodontic Imaging and Oms Imaging 8.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122427CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC201222—
+1K053010Vistadent at Complete, Model 3.1Dentsply Intl., Inc.20051—
+2K213263OnyxCephImage Instruments GmbH20230—
+2K131348OrtomedInfomed Servicios Informaticos S.L.20141—
+2K131570OrthovisionEwoosoft Co., Ltd.201319—
+3K172168WillCephHdx Will Corp.20180—
+3K173094OrthoVisionEwoosoft Co., Ltd.201718—
+4K192888EzOrthoEwoosoft Co., Ltd.202017—
+5K220903WebCephAssemblecircle Corp.20222—
+5K210187Overjet Dental AssistOverjet, Inc.20216—
+5K202948EzOrthoEwoosoft Co., Ltd.20206—
+6K260851Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp.20260—
+6K243230Second Opinion® BLEPearl, Inc.20250—
+6K231396CEPHX- Cephalometric Analysis SoftwareOrca Dental AI, Ltd.20241—
+6K232440Adravision PerioAdra Corporation20230—
+6K230144Denti.AI DetectDenti.Ai Technology, Inc.20231—
+6K223296Videa Perio AssistVideahealth, Inc.20230—
+6K211793EzOrthoEwoosoft Co., Ltd.20215—
+7K250525Second Opinion® PanoramicPearl, Inc.20250—
+7K243005AudaxCeph Cephalogram Analysis SoftwareAudax D.O.O.20250—
+7K220003EzOrtho v1.3Ewoosoft Co., Ltd.20224—
+8K222054Denti.AI Auto-ChartDenti.Ai Technology, Inc.20223—
+9K233590Overjet Charting AssistOverjet, Inc.20242—
+10K241684Overjet Charting AssistOverjet, Inc.20241—
+11K261059Overjet Multi-Image Caries and Charting AssistOverjet, Inc.20260—