FDA.reportPublic FDA data

Ortho System

Primary DI
05902729753487
Brand
Ortho System
Company
3shape A/S
Model
85.x
Device description
Ortho System is a software system intended for use as a medical front-end for orthodontic clinics and laboratories. It supports orthodontic diagnosis, treatment planning and follow-up, CAD modelling of orthodontic appliances and indirect bonding as well as archiving of case information.
Published
2021-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNNOrthodontic Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNNOrthodontic SoftwareDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05902729753487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05902729753487059027297534875902729753487

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4570272620support@3shape.com

Regulatory Flags#

DUNS number
306826012
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05902729750356Lab ScannerE12017-08-14
05902729750417Lab ScannerE1N2017-08-14
05902729752237Abutment Design2017-1 (R1.1)2020-10-22
05902729754019AutomateR2b2024-09-27
05902729753913AutomateR1.3 2024-01-22
05902729753845Implant StudioR1.42023-07-27
059027297508373Shape Scan PostsAPLsys2017-08-24
059027297508443Shape Scan PostsAPLbox2017-08-24
059027297508513Shape Scan PostsAL1.42017-08-24
059027297508683Shape Scan PostsAS1.42017-08-24
059027297508753Shape Scan PostsAL1.62017-08-24
059027297508823Shape Scan PostsAS1.62017-08-24
059027297508993Shape Scan PostsAL1.72017-08-24
059027297509053Shape Scan PostsAS1.72017-08-24
059027297509123Shape Scan PostsPIVsys2017-08-24
059027297509293Shape Scan PostsPIVbox2017-08-24
059027297509363Shape Scan PostsPL1.22017-08-24
059027297509433Shape Scan PostsPS1.22017-08-24
059027297509503Shape Scan PostsPL1.32017-08-24
059027297509673Shape Scan PostsPS1.32017-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860002991078Brius PlannerBrius Technologies IncPNN2026-06-05
D775BMARPEL0MARPEGreat Lakes Dental Technologies, Ltd.PNN2026-05-10
D775BMARPEP0MARPEGreat Lakes Dental Technologies, Ltd.PNN2026-05-10
06977207040662Angel AlignerShanghai EA Medical Instruments Co., Ltd.PNN2026-05-08
08437023642016NemoCastSOFTWARE NEMOTEC SLPNN2026-04-23
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCPNN2026-04-13
00860012168521Archform Orthodontic SoftwareArchform Inc.PNN2025-07-22
D769O3D0Orchestrate 3DPARK DENTAL RESEARCH CORPPNN2025-07-17
08800026700869Medit Orthodontic SuiteMedit Corp.PNN2025-05-29
D16420251Progressive Orthodontics AppPROGRESSIVE AMERICA, INC.PNN2025-04-30
00810060226346Blue Sky Bio, LLC.BLUE SKY BIO LLCPNN2025-02-20
00860461001776uLab Systems uDesignUlab Systems, Inc.PNN2025-01-28
D16409625Progressive Orthodontics AppPROGRESSIVE AMERICA, INC.PNN2024-11-07
00810060226063Blue Sky Bio, LLC.BLUE SKY BIO LLCPNN2024-06-19
08800003005031RAYDENT SWRay Co., LtdPNN2024-05-23
00860461001783uLab Systems uDesignUlab Systems, Inc.PNN2024-05-20
00860009273702VisionSoftsmile, Inc.PNN2024-02-16
05902729753913Automate3shape A/SPNN2024-01-22
00816063021384Invisalign Palatal HolderAlign Technology, Inc.PNN2024-01-03
00816063021391Invisalign Palatal ExpanderAlign Technology, Inc.PNN2024-01-03
D981ONYXCEPH320OnyxCeph³Image Instruments GmbHPNN2024-01-02
00693856000302CS MODEL+Dental Imaging Technologies CorporationPNN2023-12-13
00860011071921Arcad AlignersARCADLABPNN2023-11-17
00860461001769uLab Systems uDesignUlab Systems, Inc.PNN2023-11-02
05902729753821Automate3shape A/SPNN2023-03-28
00850018135122Inbrace Teeth Straightening System SWIFT HEALTH SYSTEMS INC.PNN2022-10-03
00860008123404Orchestrate 3D Orchestrate 3dPNN2022-06-21
00860002380087uLab Systems uDesignUlab Systems, Inc.PNN2022-04-11
00816063021360ClinCheckAlign Technology, Inc.PNN2022-02-17
00850018135009Inbrace Teeth Straightening System SWIFT HEALTH SYSTEMS INC.PNN2021-11-07