Cubit360

Primary DI
05061063480005
Brand
Cubit360
Company
MIMETRIK SOLUTIONS LIMITED
Model
Cubit360
Catalog number
FD1001
Device description
Cubit360 is a non-invasive optical scanning system intended for the digitization of dental impressions, dental models and dental prostheses for use in CAD/CAM workflows for the design and manufacture of dental restorations. The Cubit360 3D scanning system is connected to and operated using a computer and proprietary Mimetrik software. Neither the scanning unit nor the operating software can be used in isolation. The system is intended for use by trained dental professionals in dental laboratory or dental practice environments. Cubit360 is not intended for direct patient scanning, intraoral use, diagnosis, or treatment planning.
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KZNScanner, Color

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZNScanner, ColorDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05061063480005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05061063480005050610634800055061063480005

GMDN Terms#

Term, Definition table
TermDefinition
Dental milling system, CAD/CAM, laboratoryAn assembly of 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 and final fitting to the patient.

Regulatory Flags#

DUNS number
225697795
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E239D51351BlueSprayDreve Dentamid GmbHKZN2016-09-28