Opera System®
Catalogue number MetiSmile, listed by Shining 3D Tech Co., Ltd., China, under Device, Jaw Tracking, For Monitoring Jaw Positions. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shining 3D Tech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 3 |
Record
| Listed by | Shining 3D Tech Co., Ltd., China |
|---|---|
| FDA product code | NFS |
| Device type | Device, Jaw Tracking, For Monitoring Jaw Positions |
| Device class | Class 1 |
| Regulation | 21 CFR 872.2060 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Liquid Chemical |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MetiSmile | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nobilium | Cmp Industries, LLC | 87 |
| Shining 3D® | Shining 3D Tech Co., Ltd. | 5 |
| JMA Optic | Zebris Medical Gmbh | 4 |
| zebris for ceramill | Zebris Medical Gmbh | 2 |
| PlaneAnalyser II | Zebris Medical Gmbh | 2 |
| Tizian JMA Optic | Zebris Medical Gmbh | 2 |
| Tech In Motion | Modjaw | 2 |
| PlaneAnalyser II USB | Zebris Medical Gmbh | 2 |
| zebris for ceramill USB | Zebris Medical Gmbh | 2 |
| ARCUSdigma 3 USB | Zebris Medical Gmbh | 2 |
| ARCUSdigma 3 | Zebris Medical Gmbh | 2 |
| Plane Analyse DigiPro | Zebris Medical Gmbh | 2 |
Showing 12 of 49. All products under Device, Jaw Tracking, For Monitoring Jaw Positions
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.