Pen Tracker
The pen is used in order to collect positioning of reference points in space. The pen is used to calibrate the precision of the device.
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 | Modjaw, France |
|---|---|
| FDA product code | NFS |
| Device type | Device, Jaw Tracking, For Monitoring Jaw Positions |
| Device class | Class 1 |
| Regulation | 21 CFR 872.2060 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-02-23 |
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, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TALLY | 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.