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 |