Intraoral Camera
Catalogue number Ordinary model, standard model, luxury m, listed by Denjoy Dental Co., Ltd., China, under Camera, Cine, Endoscopic, With Audio. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Hunan (1), Zhejiang (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Tonglu Youshi Medical Instrument Co., Ltd. | Tonglu | Zhejiang | Manufacturer | 10 |
| Dongguan Magenta Medical Equipment Co., Ltd. | Dongguan | Guangdong | Manufacturer | 6 |
Record
| Listed by | Denjoy Dental Co., Ltd., China |
|---|---|
| FDA product code | FTS |
| Device type | Camera, Cine, Endoscopic, With Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-02-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Ordinary model, standard model, luxury model | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Telecam | Karl Storz GmbH & Co. KG | 2 |
| JMU | JMU Dental, Inc | 2 |
| Camera, Cine, Endoscopic, With Audio | Karl Storz GmbH & Co. KG | 1 |
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.