The following data is part of a premarket notification filed by Williams Dental Co., Inc. with the FDA for Apexit Root Canal Sealer.
| Device ID | K893794 |
| 510k Number | K893794 |
| Device Name: | APEXIT ROOT CANAL SEALER |
| Classification | Resin, Root Canal Filling |
| Applicant | WILLIAMS DENTAL CO., INC. 2948 MAIN ST. Buffalo, NY 14214 |
| Contact | L Severance |
| Correspondent | L Severance WILLIAMS DENTAL CO., INC. 2948 MAIN ST. Buffalo, NY 14214 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-22 |
| Decision Date | 1989-11-29 |