FDA.reportPublic FDA data

Scanner S600 ARTI

Primary DI
D800BG000838
Brand
Scanner S600 ARTI
Company
ZIRKONZAHN SRL
Model
BG000838
Device description
Scanner S600 ARTI
Published
2021-06-23
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

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
D800BG000838PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental CAD/CAM system, laboratoryAn assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations and/or orthodontic appliances (archwires) produced in the dental laboratory. It typically includes three-dimensional (3-D) image acquisition capabilities that provide values (measurements) from, e.g., casts, models or chairside in vivo acquisition to acquire the prescription values for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for production of the actual device(s) for delivery for final fitting to the patient.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
564251911
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D800ZBAC6105TRA0Printer Resin Surgical Guide Transpa (500g)ZBAC6105TRA2026-05-20
D800ZBAC6305RAY0Printer Resin X-Ray Temporary (500g)ZBAC6305RAY2026-05-20
D800ZBAC6405A010Printer Resin Denture Tooth Temporary A1 (500g)ZBAC6405A012026-05-20
D800ZBAC6405A020Printer Resin Denture Tooth Temporary A2 (500g)ZBAC6405A022026-05-20
D800ZBAC6405A030Printer Resin Denture Tooth Temporary A3 (500g)ZBAC6405A032026-05-20
D800ZBAC6405A040Printer Resin Denture Tooth Temporary A4 (500g)ZBAC6405A042026-05-20
D800ZBAC6405A350Printer Resin Denture Tooth Temporary A3,5 (500g)ZBAC6405A352026-05-20
D800ZBAC6405B010Printer Resin Denture Tooth Temporary B1 (500g)ZBAC6405B012026-05-20
D800ZBAC6405B020Printer Resin Denture Tooth Temporary B2 (500g)ZBAC6405B022026-05-20
D800ZBAC6405B030Printer Resin Denture Tooth Temporary B3 (500g)ZBAC6405B032026-05-20
D800ZBAC6405B040Printer Resin Denture Tooth Temporary B4 (500g)ZBAC6405B042026-05-20
D800ZBAC6405BLE0Printer Resin Denture Tooth Temporary Bleach (500g)ZBAC6405BLE2026-05-20
D800ZBAC6405C010Printer Resin Denture Tooth Temporary C1 (500g)ZBAC6405C012026-05-20
D800ZBAC6405C020Printer Resin Denture Tooth Temporary C2 (500g)ZBAC6405C022026-05-20
D800ZBAC6405C030Printer Resin Denture Tooth Temporary C3 (500g)ZBAC6405C032026-05-20
D800ZBAC6405C040Printer Resin Denture Tooth Temporary C4 (500g)ZBAC6405C042026-05-20
D800ZBAC6405D020Printer Resin Denture Tooth Temporary D2 (500g)ZBAC6405D022026-05-20
D800ZBAC6405D030Printer Resin Denture Tooth Temporary D3 (500g)ZBAC6405D032026-05-20
D800ZBAC6405D040Printer Resin Denture Tooth Temporary D4 (500g)ZBAC6405D042026-05-20
D800ZBAC6505TIA0Printer Resin Denture Base Temporary A (500g)ZBAC6505TIA2026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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