3Shape Ortho System

Primary DI
05902768365283
Brand
3Shape Ortho System
Company
3shape A/S
Model
2015-1
Device description
3Shape’s Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials.
Published
2016-09-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNNOthodontic Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNNOrthodontic SoftwareDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1520860003Shape Ortho System3Shape A/S2016-04-28PNN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05902768365283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05902768365283059027683652835902768365283

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
05902729753487Ortho System85.x2021-05-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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00816063021391Invisalign Palatal ExpanderAlign Technology, Inc.PNN2024-01-03
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00693856000302CS MODEL+Dental Imaging Technologies CorporationPNN2023-12-13
00860011071921Arcad AlignersARCADLABPNN2023-11-17
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05902729753821Automate3shape A/SPNN2023-03-28
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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
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