The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical…
The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for CamX Spectra Caries Detection Aid | Listed by | AIR Techniques, Inc., United States |
| FDA product code | NBL |
| Device type | Light-Induced Fluorescence Caries Detector |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1745 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K090169 |
| Record published | 2016-09-15 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature 0 to 70 °C |
| Packaging | Box |
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.