Help: Ex Plaque F
Cleanser for the removal of tartar and plaque on dental prostheses, liquid
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Zhongshan BestClean Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 12 |
Record
| Listed by | Renfert Gmbh, Germany |
|---|---|
| FDA product code | NUX |
| Device type | Cleanser, Denture, Prescription |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3520 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 41 to 104 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 67000100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| help:ex plaque p | Renfert Gmbh | 1 |
| temp:ex | Renfert Gmbh | 1 |
| help:ex discolor f | Renfert Gmbh | 1 |
| help:ex plaque p, sample | Renfert Gmbh | 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.