Sonendo 17% Edta
Sonendo EDTA is a 17% EDTA chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin.
1manufacturer
1catalogue number
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 | Sonendo, Inc., 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, Complaint-file establishment, Manufacturer |
| 510(k) | K961089 |
| Record published | 2017-02-08 |
| Record revised | 2018-07-06 (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 | Handling environment temperature 5 to 27 °C; Storage environment temperature up to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG-008-00001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Roydent | Roydent Dental Products, Inc. | 4 |
| Edta Solution, 17% | Pulpdent Corporation | 4 |
| File-Rite™ | Pulpdent Corporation | 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.