Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
Device Facts
| Record ID | K240446 |
|---|---|
| Device Name | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + |
| Applicant | Shiva Products |
| Product Code | KIF · Dental |
| Decision Date | Jul 30, 2024 |
| 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.
