FDA.reportPublic FDA data

CAD/CAM software

Definition
A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.
GUDID devices
102
Last updated
2026-09-04 23:10:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05404028000922SurgiCase PlannerMaterialise NVSurgiCase Knee Planner2025-05-14
05404028001028SurgiCase PlannerMaterialise NVSurgiCase Shoulder Planner2025-08-28
05404028001257SurgiCase PlannerMaterialise NVSurgiCase Knee Planner2026-05-28
E314SURGICASEKNEEPLAN0SurgiCase PlannerMaterialise NVSurgiCase Knee Planner2018-10-17
E314SURGICASESHOULPLAN0SurgiCase PlannerMaterialise NVSurgiCase Shoulder Planner2018-10-17
04262352354897DS Core RestoZetta25 AG042623523548972026-08-14
D745701181MIL00160fastdesign.ioJames R. Glidewell, Dental Ceramics, Inc.70-1181-MIL00162018-10-19
D745701181MIL001610150fastdesign.ioPrismatik Dentalcraft, Inc70-1181-MIL00162026-03-16
D745701181MIL046710150fastdesign.ioPrismatik Dentalcraft, Inc70-1181-MIL04672026-03-16
D745701197FTD00010FinalTouchJames R. Glidewell, Dental Ceramics, Inc.70-1197-FTD00012022-09-14
05404028001288SurgiCase PlannerMaterialise NVSurgiCase Shoulder Planner2026-07-16
00860002991078Brius PlannerBrius Technologies IncVarious2026-06-05
00816063023197iTero Lumina SoftwareAlign Technology, Inc.2259692025-09-16
05404028000151MimicsMaterialise NVMimics Medical2025-11-04
05404028000809Materialise Mimics Enlight CMFMaterialise NVOrthognathic Planner2024-09-05
054040280009773-maticMaterialise NV3-matic Medical2025-11-04
05404028001080Materialise Mimics Enlight CMFMaterialise NVOrthognathic and Trauma Planner2026-04-10
05404028001097Materialise Mimics Enlight CMFMaterialise NVReconstruction Planner2026-04-10
05404028001103Materialise Mimics Enlight CMFMaterialise NVSplint Designer2026-04-10
05404028001196Mimics Cardiac PlannerMaterialise NVMimics Cardiac Planner TAVR2026-05-15
05404028001202Mimics Automatic AlgorithmsMaterialise NVMimics Automatic Algorithms CMF Orthognathic CT CB2026-04-20
05404028001219Mimics Automatic Algorithms Materialise NVMimics Automatic Algorithms CMF Reconstruction CT 2026-04-20
05404028001226Mimics Automatic Algorithms Materialise NVMimics Automatic Algorithms Knee MRI2026-04-20
06970163089140SHINING 3D®Shining 3D Tech Co., Ltd.SN3D-AI2026-05-20
06977207040662Angel AlignerShanghai EA Medical Instruments Co., Ltd.iOrtho2026-05-08
08800130800080Laon OrthoLaon Medi Inc.2.02026-05-07
05404028001158Mimics FlowMaterialise NVMimics Flow2026-03-23
05404028001172SurgiCase OnlineMaterialise NVSurgiCase Online2026-03-23
05404028001189ProPlan CMF Materialise NVProPlan CMF Online 2026-03-23
05404028000861Mimics Thoracic PlannerMaterialise NVMimics Thoracic Planner2026-03-20
05404028000830Mimics Automatic AlgorithmsMaterialise NVMimics Automatic Algorithms CMF Orthognathic CT CB2026-01-30
05404028001042Mimics Automatic Algorithms Materialise NVMimics Automatic Algorithms CMF Reconstruction CT 2026-01-30
05404028001073Mimics Automatic Algorithms Materialise NVMimics Automatic Algorithms Shoulder Arthroplasty 2026-01-30
06429810209054SMART PCFDDisior Oy12026-01-27
00816063023760GumlinesAlign Technology, Inc.2267972026-01-01
05404028001110SurgiCase Planner Materialise NVSurgiCase Shoulder Planner 2025-12-17
05404028001035Mimics Cardiac PlannerMaterialise NVMimics Cardiac Planner TTVR2025-12-15
04262352350042DS Core RestoZetta25 AG042623523500422025-09-09
E27668534800CAD/CAM SoftwareSIRONA Dental Systems GmbH68534802025-08-19
00860012168521Archform Orthodontic SoftwareArchform Inc.Various2025-07-22
D769O3D0Orchestrate 3DPARK DENTAL RESEARCH CORPO3D2025-07-17
08800026700869Medit Orthodontic SuiteMedit Corp.2.02025-05-29
05404028000946Materialise Mimics Enlight CMFMaterialise NVOrthognathic and Trauma Planner2025-05-12
05404028000953Materialise Mimics Enlight CMFMaterialise NVReconstruction Planner2025-05-12
D16420251Progressive Orthodontics AppPROGRESSIVE AMERICA, INC.2.02025-04-30
05404028000199Materialise Mimics EnlightMaterialise NVMaterialise Mimics Enlight2025-03-07
05404028000281SurgiCase OOSMaterialise NVSurgiCase Mobile2025-03-07
00816063023067iTero Lumina ProAlign Technology, Inc.2259792025-03-06
04262352350035DI ScanZetta25 AG042623523500352025-02-21
05404028000090MimicsMaterialise NVKnee MRI2024-12-03
05404028000335MimicsMaterialise NVHeart CT2024-12-03
05404028000359MimicsMaterialise NVKnee CT2024-12-03
054040280007003-maticMaterialise NV3-matic Medical2024-12-03
05404028000717MimicsMaterialise NVMimics Medical2024-12-03
05404028000885Mimics PluginMaterialise NVGRP Plugin2024-12-03
05404028000892Mimics PluginMaterialise NVRT Plugin2024-12-03
05404028000908Mimics FlowMaterialise NVMimics Flow2024-12-03
08809692507000AiD RegenROKIT HEALTHCARE Inc.AIDR-0012024-11-14
D16409625Progressive Orthodontics AppPROGRESSIVE AMERICA, INC.0.9.62024-11-07
05404028000762Mimics Cardiac PlannerMaterialise NVMimics Cardiac Planner2024-10-16
05902729754019Automate3shape A/SR2b2024-09-27
05404028000816Materialise Mimics Enlight CMFMaterialise NVReconstruction Planner2024-09-09
E27668346390CAD/CAM SoftwareSIRONA Dental Systems GmbH68346392024-08-23
E27668346470CAD/CAM SoftwareSIRONA Dental Systems GmbH68346472024-08-23
E27668346540CAD/CAM SoftwareSIRONA Dental Systems GmbH68346542024-08-23
E27668346620CAD/CAM SoftwareSIRONA Dental Systems GmbH68346622024-08-23
E27668346700CAD/CAM SoftwareSIRONA Dental Systems GmbH68346702024-08-23
E27668346880CAD/CAM SoftwareSIRONA Dental Systems GmbH68346882024-08-23
E27668346960CAD/CAM SoftwareSIRONA Dental Systems GmbH68346962024-08-23
E27668347040CAD/CAM SoftwareSIRONA Dental Systems GmbH68347042024-08-23
06429810209030SMART Bun-Yo-Matic™ CTDisior Oy1.02024-07-12
06429810209047SMART Bun-Yo-Matic™ XrayDisior Oy1.02024-07-12
08800026700203Medit ClinicCADMedit Corp.Medit ClinicCAD2024-06-21
08800019600909Lilivis CAD L-CADHuvitz Co., Ltd.L-CAD2024-05-27
08800003005031RAYDENT SWRay Co., Ltd2.2.0.02024-05-23
E27668208930CAD/CAM SoftwareSIRONA Dental Systems GmbH68208932024-05-08
04262352359243DI ScanZetta25 AG042623523592432024-04-18
05404028000571Mimics Cardiac PlannerMaterialise NVMimics Cardiac Planner2024-03-15
00860009273702VisionSoftsmile, Inc.Vision 12024-02-16
06429810209221BonelogicDisior OyBonelogic 2.22024-01-15