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Product alone (without Box and accessories) The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to…
Product alone (without Box and accessories) The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details that are invisible to the naked eye or with a mirror (thanks to its magnification). In CARIO mode, the camera helps the dental practitioner to highlight carious warning on pits and fissures of the occlusal side of the teeth. In DAYLIGHT mode, the camera enables you to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). In PERIO mode, the camera helps the dental practitioner to see the presence of dental plaque but also to highlight gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing). This mode offers to the dentist and/or hygienist a tool for an improved communication, motivation and education of his/her patients, who will then become aware of their oral health condition.
Who Else Makes It
Concentrated in Guangxi (1), Henan (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Guangzhou Stars Pulse Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 3 |
Record
| Listed by | Sopro, France |
|---|---|
| FDA product code | NYH |
| Device type | Plaque Disclosing Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1740 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2019-03-12 |
| Record revised | 2020-12-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 54.0225.00 DOCK ANALOG 7M | In distribution | |
| 54.0293.00 DOCK ANALOG 2M G3 | In distribution | |
| MINI DOCK U_USB2 7M | In distribution | |
| DOCK MU_VIDEO – ADEC 500 – 5M | In distribution | |
| MINI DOCK USB2 | In distribution | |
| SOPROCARE N | In distribution | |
| DOCK MU USB2 ADEC 300 7M GR3 | In distribution | |
| MINI DOCK USB2 STRAUMANN | In distribution | |
| DOCK U USB ADEC 500 SURG 1.5M | In distribution | |
| DOCK U USB ADEC 300 2M GR3 | In distribution | |
| MINI DOCK U_USB2 | In distribution | |
| 54.0310.00 DOCK ANALOG 2M G3 | In distribution | |
| DOCK U_USB2 5M ADEC 500 | In distribution | |
| SOPROCARE NTSC | In distribution | |
| DOCK U_USB2 5M ADEC 300 | In distribution | |
| CAMERA S717 Fisrt NTSC | In distribution | |
| SOPROCARE NTSC STRAUMANN | In distribution | |
| MINI DOCK U_USB2 7M | In distribution | |
| SOPROCARE PAL STRAUMANN | In distribution | |
| DOCK MU USB2 ADEC 300 2M GR3 | In distribution | |
| MINI DOCK U_USB2 5M | In distribution | |
| CAMERA S950 NTSC SOPROCARE WS | In distribution | |
| DOCK MU USB2 FUSIBLE ADEC 7M S | In distribution | |
| CAMERA S950 PAL SOPROCARE WS | In distribution | |
| CAMERA S950 NTSC SOPROCARE | In distribution | |
| DOCK U USB BELMONT 7M BIEN AIR | In distribution | |
| SOPROCARE NTSC | In distribution | |
| DOCK U USB ADEC 500 SURG 1.5M | In distribution | |
| MINI DOCK U_USB2 5M | In distribution | |
| CONTROLLER – VIDEO – 2.5M | In distribution | |
| MINI DOCK U_USB2 5M | In distribution | |
| CONTROLLER – USB2 – 2.5M | In distribution | |
| MINI USB2 DOCK | In distribution | |
| CAMERA S950 NTSC SOPROCARE WS | In distribution | |
| DOCK MU USB2 ADEC 300 2M GR3 | In distribution | |
| DOCK MU_USB2 – FEDESA – 7M – S | In distribution | |
| CAMERA S950 PAL SOPROCARE WS | In distribution | |
| DOCK U USB ADEC 300 7M GR3 | In distribution | |
| MINI USB2 DOCK | In distribution | |
| MINI DOCK U_USB2 1.5M | In distribution | |
| SOPROCARE P | In distribution | |
| MINI DOCK U_USB2 2M | In distribution | |
| DOCK U USB ADEC 500 7M SF6 | In distribution | |
| CONTROLLER – VIDEO – 2.5M | In distribution | |
| DOCK U USB FEDESA 7M BIEN AIR | In distribution | |
| MINI DOCK U_USB2 7M | In distribution | |
| MODULE USB2 2M | In distribution | |
| MINI DOCK U_USB2 5M | In distribution | |
| DOCK MU USB2 ADEC 300 2M GR3 | In distribution | |
| DOCK U USB ADEC 500 2M SF6 | In distribution | |
| CONTROLLER – USB2 – 2.5M | In distribution | |
| KIT SOPROCARE PAL with Mini Dock USB2 | In distribution | |
| CAMERA S950 NTSC SOPROCARE | In distribution | |
| DOCK U USB ADEC 300 2M GR3 | In distribution | |
| DOCK U USB FEDESA 7M BIEN AIR | In distribution | |
| DOCK U USB BELMONT 7M BIEN AIR | In distribution | |
| KIT SOPROCARE NTSC with Mini Dock USB2 | In distribution | |
| DOCK U USB ADEC 500 7M SF6 | In distribution | |
| 54.0227.00 DOCK ANALOG 2M | In distribution | |
| DOCK U USB ADEC 500 2M SF6 | In distribution | |
| MINI DOCK U_USB2 7M | In distribution | |
| CAMERA S617 NTSC | In distribution | |
| 54.0584.00 REV A MINI DOCK U_USB2 1M54 | In distribution | |
| DOCK U USB ADEC 300 7M GR3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Owandy | Sopro | 3 |
| GC Tri Plaque ID Gel™ | GC America Inc. | 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.