FDA.reportPublic FDA data

3Shape Dental System

Primary DI
05902768365092
Brand
3Shape Dental System
Company
3shape A/S
Model
2016-1
Device description
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
Published
2016-08-25
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
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05902768365092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05902768365092059027683650925902768365092

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
Premarket exempt
true
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
06970163089140SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-20
06975456126007UP3D Intraoral ScannerShenzhen UP3d Technology Co., Ltd.NOF2026-05-18
06970163084022SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084039SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084046SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
08800026700760Medit Link ExpressMedit Corp.NOF2026-04-28
08800026700883Medit Link ExpressMedit Corp.NOF2026-04-28
06973993442499Intraoral ScannerAlliedstar Medical Equipment Co., Ltd.NOF2026-04-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCNOF2026-04-13
06970163089966SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089973SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089836SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-16
D745701181MIL001610150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
D745701181MIL046710150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
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07540209957611MicronMapperClaronav IncNOF2026-02-10
07540209957628MicronMapperClaronav IncNOF2026-02-10
07540209957635MicronMapperClaronav IncNOF2026-02-10
07540209957642MicronMapperClaronav IncNOF2026-02-10