SEALAPEX 4
Device Facts
| Record ID | K010940 |
|---|---|
| Device Name | SEALAPEX 4 |
| Applicant | Sybron Dental Specialties, Inc. |
| Product Code | KIF · Dental |
| Decision Date | Jun 20, 2001 |
| 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.
