OVO IOS
OVO IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impression, or stone models for use in the computer aided design and…
OVO IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impression, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. OVO IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
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 | 3D Imaging And Simulation Corp. Americas, United States |
|---|---|
| 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 | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-03-22 |
| Record revised | 2023-04-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Handling environment temperature 10 to 30 °C; Handling environment humidity 10 to 80 % RH; Storage environment humidity 10 to 80 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IOS-FP-71-003 | 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.