510(k) Report

Devices descending from K110300

20 later devices reach Simplant 2011 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172239Simplant 18Dentsply Sirona20180—
+1K1711153D Endo SoftwareDentsply Sirona20171—
+1K161118SIMPLANT Online Case Review and SIMPLANT EditorDentsply Sirona20160—
+1K153091Implant 3DMedia Lab S.R.L.20160—
+1K152078Implant Studio 20153Shape Medical A/S20157—
+1K141570Implant Studio3Shape Medical A/S20148—
+1K120733Simplant GOMaterialise Dental NV20120—
+1K113739Simplant Immediate Smile Dental Care SystemMaterialise Dental NV20123—
+1K112679Simplant Navigator Personalized Dental Care SystemMaterialise Dental NV20120—
+2K253902RealGUIDE3DIEMME SRL20260—
+2K200078VARO Plan3D Industrial Imaging Co., Ltd.20200—
+2K183458exoplan 2.3Exocad GmbH20191—
+2K1730413DIEMME RealGUIDE3Diemme, Ltd.20182—
+2K180629DentiqGuide3D Industrial Imaging Co., Ltd.20181—
+2K180262SICAT EndoSicat GmbH & Co. KG20180—
+2K170849SIMPLANT GuideDentsply Sirona20172—
+3K213302exoplanExocad GmbH202201
+3K203765ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter…Zirkonzahn Srl20210—
+3K193405Simplant Digital GuideDentsply Sirona20200—
+3K190059CEREC GuidesDentsply Sirona20190—