The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Lofric Elle.
| Device ID | K211212 |
| 510k Number | K211212 |
| Device Name: | LoFric Elle |
| Classification | Catheter, Straight |
| Applicant | Dentsply Sirona 221 W Philadelphia Street, Suite 60W York, PA 17401 |
| Contact | Rebecca Sporer |
| Correspondent | Rebecca Sporer Dentsply Sirona 221 W Philadelphia Street, Suite 60W York, PA 17401 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2022-02-17 |