K240446 is an FDA 510(k) clearance for the Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +. This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).
Submitted by Shiva Products (Palghar, IN). The FDA issued a Cleared decision on July 30, 2024, 166 days after receiving the submission on February 15, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K240446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2024 |
| Decision Date | July 30, 2024 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KIF - Resin, Root Canal Filling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3820 |