The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Lee Endofill, Root Canal Filling Resin.
| Device ID | K810923 |
| 510k Number | K810923 |
| Device Name: | LEE ENDOFILL, ROOT CANAL FILLING RESIN |
| Classification | Resin, Root Canal Filling |
| Applicant | LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-06 |
| Decision Date | 1981-04-21 |