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…
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.
Who Else Makes It
Registered in Hebei.
Record
Regulatory record for Cubit360 | Listed by | Mimetrik Solutions Ltd, United Kingdom |
| FDA product code | KZN |
| Device type | Scanner, Color |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3661 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-04-07 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.