FDA.reportPublic FDA data

Abutment Design

Primary DI
05902729752237
Brand
Abutment Design
Company
3shape A/S
Model
2017-1 (R1.1)
Device description
Dental CAD Software
Published
2020-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
PNPDental Abutment Design Software For Dental Laboratory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2
PNPDental Abutment Design Software For Dental LaboratoryDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05902729752237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05902729752237059027297522375902729752237

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

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
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
059027297509673Shape Scan PostsPS1.32017-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435566602719IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566602764IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566601101IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-07-14
08435566609091IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609107IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609114IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609121IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609138IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609145IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609152IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609169IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609176IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609183IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609190IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609589IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609596IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609602IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609619IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609626IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609633IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609640IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610691IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610707IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610714IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610721IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610776IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610783IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610790IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610806IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566603839IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-16