K7 Evaluation System-CMS
Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The…
Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training.
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 | Myotronics-Noromed, Inc., United States |
|---|---|
| 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 |
| Record published | 2016-09-19 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K7/CMS | 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.