The following data is part of a premarket notification filed by Shizai Corp. with the FDA for Fr Root Canal Filler.
| Device ID | K830763 |
| 510k Number | K830763 |
| Device Name: | FR ROOT CANAL FILLER |
| Classification | Resin, Root Canal Filling |
| Applicant | SHIZAI CORP. 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 | 1983-03-10 |
| Decision Date | 1983-08-26 |