Iray
The iScan system is an intraoral scanner that uses the optical scanning method to obtain the three-dimensional shape feature data of the surfaces of teeth, gums, and other tissues. It…
The iScan system is an intraoral scanner that uses the optical scanning method to obtain the three-dimensional shape feature data of the surfaces of teeth, gums, and other tissues. It outputs the three-dimensional digital impression data. This device is intended for use in medical institutions, providing 3D scanning for adult and pediatric patients undergoing dental treatments like restorations, orthodontics, and implants.
Who Else Makes It
Concentrated in Guangdong (14), Jiangsu (6), Sichuan (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Envista (Suzhou) Medical Device Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Ningbo Runyes Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 4 |
| BLZ Technology (Wuhan) Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 3 |
| iRay Imaging Technology Taicang Limited | Taicang | Jiangsu | Contract manufacturer | 3 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
Showing 12 of 36. All 36 manufacturers in China registered for System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Record
| Listed by | iRay Group, China |
|---|---|
| FDA product code | NOF |
| Device type | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3661 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-01-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, High-level Disinfectant |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| iScan | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lab Scanner | 3Shape A/S | 60 |
| Shining 3D® | Shining 3D Tech Co., Ltd. | 58 |
| Trios 3 | 3SHAPE Trios A/S | 57 |
| 3Shape Scan Posts | 3Shape A/S | 38 |
| MicronMapper | ClaroNav Inc. | 35 |
| 3Shape Scan Bodies | 3Shape A/S | 34 |
| Trios | 3SHAPE Trios A/S | 31 |
| Alliedstar | Alliedstar Medical Equipment Co., Ltd. | 23 |
| 3Shape | 3Shape A/S | 18 |
| Trios® 4 | 3SHAPE Trios A/S | 13 |
| PlanScan | D4D Technologies | 9 |
| Scanner S600 | Zirkonzahn SRL | 9 |
Showing 12 of 263. All products under System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
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.