APEXIT ROOT CANAL SEALER
Device Facts
| Record ID | K893794 |
|---|---|
| Device Name | APEXIT ROOT CANAL SEALER |
| Applicant | Williams Dental Co., Inc. |
| Product Code | KIF · Dental |
| Decision Date | Nov 29, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3820 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.