This device is an oral camera device that can be magnified in the light of the inside of the mouth, and is used by dentists to photograph the inside of the mouth during oral examination. It…
This device is an oral camera device that can be magnified in the light of the inside of the mouth, and is used by dentists to photograph the inside of the mouth during oral examination. It consists of a camera head, a battery, a charging cradle, and a receiver module. Investigate the light from the mouth LED to capture the image from the camera module and wirelessly transmit the data via UWB. Additionally, the transmitted image can be viewed using a separate viewer program on the PC ti which the receiver module is connected.
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Osstem Implant Co., Ltd. | Listed by | Osstem Implant Co., Ltd., South Korea |
| FDA product code | QJK |
| Device type | Intraoral Camera |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3661 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-30 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
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.