3shape
The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of the topographical characteristics of teeth from dental models and impressions – for use with…
The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of the topographical characteristics of teeth from dental models and impressions → for use with CAD/CAM dental restoration design.
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 | 3Shape A/S, Denmark |
|---|---|
| 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2023-04-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 7000 to 11000 KiloPascal; Handling environment humidity 10 to 85 % RH; Handling environment temperature 15 to 35 °C; Storage environment atmospheric pressure 7000 to 11000 KiloPascal; Storage environment humidity 10 to 85 % RH; Storage environment temperature -10 to 60 °C |
| Distribution end date | 2018-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D850 | Withdrawn | |
| D2000 | Withdrawn | |
| R750 | Withdrawn | |
| D900 | Withdrawn | |
| R500 | Withdrawn | |
| D810 | Withdrawn | |
| D710 | Withdrawn | |
| D500 | Withdrawn | |
| D1000 | Withdrawn | |
| D800 | Withdrawn | |
| D700 | Withdrawn | |
| R850 | Withdrawn | |
| D750 | Withdrawn | |
| R2000 | Withdrawn | |
| R900 | Withdrawn | |
| R700 | Withdrawn | |
| R1000 | Withdrawn | |
| D900L | Withdrawn |
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 |
| 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.