Temp: Ex
Cleanser for dissolving temporary cement from dental restorations, 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 |
|---|---|---|
| 66000000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| help:ex plaque f | Renfert Gmbh | 1 |
| help:ex plaque p | 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.