Shining 3d®
This is an intraoral scanner that works with the supplied software programs. By performing scanning directly and digitally acquiring and saving the 2D/3D color images of teeth, gingiva and…
This is an intraoral scanner that works with the supplied software programs. By performing scanning directly and digitally acquiring and saving the 2D/3D color images of teeth, gingiva and oral mucosa, the scanner is available for patients with needs of orthodontic, implant, and restoration.
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 | Shining 3D Tech Co., Ltd., 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 | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-09-02 |
| Record revised | 2023-08-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, High-level Disinfectant |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Atip LFS | In distribution | |
| Atip EAL | In distribution | |
| Aoralscan Lync | In distribution | |
| Atip EL | In distribution | |
| Aoralscan Elf (P) | In distribution | |
| Aoralscan 3 Wireless | In distribution | |
| Atip ES | In distribution | |
| Atip EB | In distribution | |
| Atip LFB | In distribution | |
| Aoralscan Lync | In distribution | |
| Aoralscan Elite Wireless | In distribution | |
| Aoralscan Lync | In distribution | |
| SN3D-AI | In distribution | |
| Aoralscan Elite Wireless | In distribution | |
| Aoralscan L | In distribution | |
| Aoralscan Elite Wireless | In distribution | |
| Aoralscan Elf | In distribution | |
| Aoralscan L | In distribution | |
| Atip EL | In distribution | |
| Atip EAB | In distribution | |
| Atip EB | In distribution | |
| AGR-AS | In distribution | |
| Aoralscan Lync | In distribution | |
| DT-A | In distribution | |
| DT-AS | In distribution | |
| Aoralscan Elf (DB) | In distribution | |
| Aoralscan 3 | In distribution | |
| Aoralscan Elite | In distribution | |
| Atip 3S | In distribution | |
| Aoralscan 3 Wireless | In distribution | |
| Aoralscan 3 Wireless | In distribution | |
| Atip 3WL | In distribution | |
| Aoralscan Elf (TS) | In distribution | |
| Aoralscan Elf Pro | In distribution | |
| Aoralscan Elite Wireless | In distribution | |
| Aoralscan Lync | In distribution | |
| Aoralscan 3 Wireless NEO | In distribution | |
| Aoralscan Elite Wireless | In distribution | |
| Aoralscan 3 | In distribution | |
| Atip LFL | In distribution | |
| AGR-AB | In distribution | |
| Aoralscan Elf (CG) | In distribution | |
| Atip ES | In distribution | |
| AGR-AL | In distribution | |
| Atip 3WS | In distribution | |
| Aoralscan Elf (TS) | In distribution | |
| Aoralscan Elite Wireless | In distribution | |
| Aoralscan Elite Wireless | In distribution | |
| Aoralscan Elite | In distribution | |
| Atip 3L | In distribution | |
| Aoralscan Elf (R) | In distribution | |
| Atip EAS | In distribution | |
| QC-A | In distribution | |
| ST-A | In distribution | |
| Aoralscan Elite | In distribution | |
| Cra LF | In distribution | |
| Aoralscan Lync | In distribution | |
| Capella M5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lab Scanner | 3Shape A/S | 60 |
| 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 |
| Workstation | Zirkonzahn SRL | 8 |
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.