The following data is part of a premarket notification filed by Septodont, Inc. with the FDA for Endosolv E.
| Device ID | K780003 |
| 510k Number | K780003 |
| Device Name: | ENDOSOLV E |
| Classification | Cleanser, Root Canal |
| Applicant | SEPTODONT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-29 |
| Decision Date | 1978-01-20 |