510(k) Report

Devices descending from K053592

68 later devices reach Simplant DR. James through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133320Sicat FunctionSicat GmbH & Co. KG20142—
+1K110300Simplant 2011Materialise Dental NV201120—
+1K103723Sicat Implant V1.2Sicat GmbH & Co. KG20115—
+1K093090Galileos Implant, Version 1.7Sicat GmbH & Co. KG20090—
+1K081402Simplant Ortho ; Vistadent 3DMaterialise Dental NV20087—
+1K070713Implant Location Software-TTactile Technologies, Ltd.20070—
+1K070803InvivodentalAnatomage, Inc.200738—
+2K183676DentiqAir3D Industrial Imaging Co., Ltd.20190—
+2K192348SICAT Implant V2.0Sicat GmbH & Co. KG201901
+2K172239Simplant 18Dentsply Sirona20180—
+2K180262SICAT EndoSicat GmbH & Co. KG20180—
+2K1711153D Endo SoftwareDentsply Sirona20171—
+2K170180Will3DHdx Will Corp.20171—
+2K161118SIMPLANT Online Case Review and SIMPLANT EditorDentsply Sirona20160—
+2K153091Implant 3DMedia Lab S.R.L.20160—
+2K152078Implant Studio 20153Shape Medical A/S20157—
+2K152661HICAT AirHicat GmbH20150—
+2K141570Implant Studio3Shape Medical A/S20148—
+2K130242Maven ProNsequence20130—
+2K123519Invivo DentalAnatomage, Inc.201324—
+2K120733Simplant GOMaterialise Dental NV20120—
+2K113739Simplant Immediate Smile Dental Care SystemMaterialise Dental NV20123—
+2K112679Simplant Navigator Personalized Dental Care SystemMaterialise Dental NV20120—
+2K113543ONDEMAND3DCybermed, Inc.20119—
+3K253902RealGUIDE3DIEMME SRL20260—
+3K211114Will3DHdx Will Corp.20210—
+3K200572Planmeca RomexisPlanmeca Oy20202—
+3K200078VARO Plan3D Industrial Imaging Co., Ltd.20200—
+3K183458exoplan 2.3Exocad GmbH20191—
+3K1730413DIEMME RealGUIDE3Diemme, Ltd.20182—
+3K181926InVivo Web ViewerAnatomage, Inc.20180—
+3K180629DentiqGuide3D Industrial Imaging Co., Ltd.20181—
+3K171385Planmeca RomexisPlanmeca Oy20171—
+3K170849SIMPLANT GuideDentsply Sirona20172—
+3K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+3K140713Planmeca RomexisPlanmeca Oy201414—
+3K140093TABLEAnatomage, Inc.20144—
+3K132773Sidexis 4Sirona Dental Systems GmbH20131—
+3K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+4K260716NeowiseCefla S.C.20260—
+4K251514Overjet CBCT AssistOverjet, Inc.20250—
+4K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+4K213302exoplanExocad GmbH202201
+4K203765ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter…Zirkonzahn Srl20210—
+4K193405Simplant Digital GuideDentsply Sirona20200—
+4K192165Acteon Imaging SuiteDe Gotzen S.R.L.20200—
+4K190059CEREC GuidesDentsply Sirona20190—
+4K162799CliniviewPalodex Group OY201713—
+4K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+4K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+4K142048Emprint Procedure Planning ApplicationCovidien, LLC20143—
+5K203156DTX Studio ClinicNobel Biocare AB202010—
+5K180192Emprint Ablation Visualization ApplicationCovidien, LLC20182—
+5K172224DTX Studio diagnoseNobel Biocare AB20180—
+5K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+6K213562DTX Studio Clinic 3.0Nobel Biocare AB20229—
+6K192038Emprint Visualization ApplicationCovidien, LLC20191—
+6K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+7K252947HistoSonics® Planning ToolHistoSonics, Inc.20260—
+7K233925Relu CreatorRelu BV20246—
+7K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+7K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+8K260785DS Core CBCT AnatomyDentsply Sirona20261—
+8K252538CEPHX3DOrca Dental AI, Ltd.20260—
+8K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—
+8K243989Second Opinion® 3DPearl, Inc.20253—
+9K262127DS Core CBCT AnatomyDentsply Sirona20260—
+9K254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.20260—