Cubit360

Basic Information

• Brand Name: Cubit360
• Primary DI: 05061063480005
• Version / Model: Cubit360
• Catalog Number: FD1001
• Company Name: MIMETRIK SOLUTIONS LIMITED
• Labeler DUNS: 225697795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-07
• Public Version: 1
• Public Version Date: 2026-04-15
• Public Version Status: New
• Public Device Record Key: c5788254-8616-42d2-b3cb-f64f373cf20b

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZN	Scanner, Color	Dental	872.3661	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34713	Dental milling system, CAD/CAM, laboratory	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05061063480005	GS1