510(k) Report

Devices descending from K033849

379 later devices reach Simplant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133320Sicat FunctionSicat GmbH & Co. KG20142—
+1K113543ONDEMAND3DCybermed, Inc.20119—
+1K113404Dental 3D Planning SoftwareSymbyo Dental, LLC20111—
+1K103723Sicat Implant V1.2Sicat GmbH & Co. KG20115—
+1K093090Galileos Implant, Version 1.7Sicat GmbH & Co. KG20090—
+1K090119Sicat ImplantSicat GmbH & Co. KG20098—
+1K073449SurgicaseMaterialise NV2008143—
+1K073468MimicsMaterialise NV2008141—
+1K071636Codiagnostix (R) 5.72Ivs Solutions AG2007212
+1K070803InvivodentalAnatomage, Inc.200738—
+1K070464ONDEMAND3DCybermed, Inc.200714—
+1K061472Galileos Implant, V 1.0Sicat GmbH & Co. KG200610—
+1K0609503MATICMaterialise NV200631—
+1K052424MaxilimMedicim NV200617—
+1K060267Virtual Implant Placement (Vip) Dental Implant Surgery Planning SoftwareImplant Logic Systems, Ltd.200643—
+1K053592Simplant DR. JamesMaterialise NV200668—
+1K053155VimplantCybermed, Inc.200563—
+1K051392Bti-Scan, Version 4.0B.T.I. Biotechnology Institute, Sl.20050—
+1K050341Implant Location Software, Model 0.1.0Tactile Technologies, Ltd.20050—
+1K042212ImplantmasterI-Dent200444—
+2K222195aprevo® Digital WorkflowCarlsmed, Inc.20221—
+2K183676DentiqAir3D Industrial Imaging Co., Ltd.20190—
+2K192348SICAT Implant V2.0Sicat GmbH & Co. KG201901
+2K183105Mimics MedicalMaterialise NV201934—
+2K173083Implanter Dental Planning SoftwareImplanter, LLC20180—
+2K173619Mimics inPrintMaterialise NV201813—
+2K180262SICAT EndoSicat GmbH & Co. KG20180—
+2K170180Will3DHdx Will Corp.20171—
+2K161841D2P3D Systems, Inc.20178—
+2K161634IPS CaseDesignerNobel Biocare AB20163—
+2K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+2K152661HICAT AirHicat GmbH20150—
+2K142779Scanip; Scanip: Medical Edition; Scanip: MedSimpleware, Ltd.201542
+2K140337Brightmatter Planning SoftwareSynaptive Medical, Inc.20141—
+2K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+2K132773Sidexis 4Sirona Dental Systems GmbH20131—
+2K132636Dyonics Plan Hip Impingement Planning SystemSmith & Nephew, Inc.201314—
+2K130242Maven ProNsequence20130—
+2K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+2K130724Codiagnostix Implant Planning SoftwareStraumann USA201315—
+2K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+2K123976NobelclinicianNobel Biocare AB20133—
+2K123519Invivo DentalAnatomage, Inc.201324—
+2K120956VSP SystemMedical Modeling, Inc.201228—
+2K112389Surgicase Connect, Surgicase GuideMaterialise NV201259—
+2K111863Signature Planner,Signature GuidesMaterialise NV201271—
+2K113732Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)Brainlab AG20128—
+2K113599Surgicase ConnectMaterialise NV20124—
+2K112251Swissmeda Dental Planning SystemSwissmeda AG20124—
+2K112387Procedure Rehearsal Studio (TM)Simbionix, Ltd.201140—
+2K111641Surgicase Orthognathic Software WizardMaterialise NV20116—
+2K110300Simplant 2011Materialise Dental NV201120—
+2K102795Signature Planner; Signature GuidesMaterialise NV2011994
+2K103182Triana, Picture Archiving and Communications SystemGenoray Co., Ltd.20110—
+2K102684Xelis DentalInfinitt Co., Ltd.20102—
+2K093269Procedure Rehearsal StudioSimbionix, Ltd.201041—
+2K090607Blue Sky Bio Plan, Version .38Blue Sky Bio, LLC20092—
+2K081402Simplant Ortho ; Vistadent 3DMaterialise Dental NV20087—
+2K070713Implant Location Software-TTactile Technologies, Ltd.20070—
+2K061126AccurexCybermed, Inc.20063—
+3K254214OoopdsTaiwan Main Orthopaedic Biotechnology Co., Ltd.20260—
+3K251964Mimics Thoracic PlannerMaterialise NV20260—
+3K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+3K242647MySegmenter (v2.0.0)Mysegmenter Technologies, Inc.20250—
+3K242599aprevo® Digital PlanningCarlsmed, Inc.20240—
+3K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20243—
+3K223427Mimics Enlight CMFMaterialise NV20240—
+3K232698NemoScanSoftware Nemotec S.L.20240—
+3K231955aprevo® Digital SegmentationCarlsmed, Inc.20231—
+3K230540Patient Specific Planning Solution™ 3D Bone ModelsBiomet Manufacturing Corp20230—
+3K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+3K222987Akunah REFLECTAkunah Pty, Ltd.20231—
+3K220649ElucisRealize Medical, Inc.20230—
+3K222577TECHFIT Diagnostic ModelsTechfit Digital Surgery, Inc.20230—
+3K221511Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited20224—
+3K213684SurgiCase ViewerMaterialise NV20221—
+3K2202053D Anatomic ModelsRicoh USA, Inc.20221—
+3K211966Segment 3DPrintMedviso AB20220—
+3K212981MirrorMe3D Modeling SystemMirrorme3D, LLC20220—
+3K212570OsteoPlan SystemOsteomed, LLC20221—
+3K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+3K211114Will3DHdx Will Corp.20210—
+3K210241ImplaStationProdigident, Inc.20210—
+3K210726ImmersiveTouchImmersivetouch, Inc.20211—
+3K193301coDiagnostiXDental Wings GmbH20210—
+3K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+3K203195Simpleware ScanIP MedicalSynopsys (Northern Europe), Ltd.20213—
+3K203290BonelogicDisior, Ltd.20215—
+3K200572Planmeca RomexisPlanmeca Oy20202—
+3K192282MedCAD® AccuPlan® SystemMedcad20203—
+3K200810IPS CaseDesignerNobel Biocare AB20201—
+3K2022563Shape Implant Studio3Shape Medical A/S20201—
+3K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch20200—
+3K193369Xelis Dental 2.0Infinitt Healthcare Co., Ltd.20200—
+3K190767AnatomicAlignerThe Methodist Hospital Research Institute D/B/A Houston20200—
+3K192040AVIEW ModelerCoreline Soft Co., Ltd.20190—
+3K191026Medip ProMedical IP Co., Ltd.20192—
+3K183489D2P3D Systems, Inc.20196—
+3K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+3K190096R2GATEMegagen Implant Co., Ltd.20191—