Roydent
C.L. Canal Lubricant (20 Count
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
Record
| Listed by | Roydent Dental Products, Inc., United States |
|---|---|
| FDA product code | EKL |
| Device type | Point, Silver, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3840 |
| Record published | 2016-10-07 |
| Record revised | 2019-07-12 (version 3) |
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 | Special storage condition: Store in a Cool Dry Place |
| Sizes | Total volume 2 to 8 Fluid Ounce; total volume 2.5 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PL209 | Total Volume 8 Fluid Ounce | In distribution | |
| 103 | Total Volume 2.5 ml | 20 | In distribution |
| PL208 | Total Volume 2 Fluid Ounce | In distribution | |
| 101 | Total Volume 2.5 ml | 150 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Edta Solution, 17% | Pulpdent Corporation | 4 |
| File-Rite™ | Pulpdent Corporation | 1 |
| Sonendo 17% Edta | Sonendo, 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.