File-Rite™
KIT: 4 x 5 gm syringes File-Rite + 50 applicator tips Canal Lubricant and Chelating Agent
1manufacturer
1catalogue number
1510(k) clearance
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 | Pulpdent Corporation, United States |
|---|---|
| FDA product code | EKL |
| Device type | Point, Silver, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3840 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-08-11 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FILE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Roydent | Roydent Dental Products, Inc. | 4 |
| Edta Solution, 17% | Pulpdent Corporation | 4 |
| Sonendo 17% Edta | Sonendo, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K961089 | 1996-04-23 |
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.