K212563 is an FDA 510(k) clearance for the CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid. This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).
Submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on May 23, 2022, 283 days after receiving the submission on August 13, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K212563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2021 |
| Decision Date | May 23, 2022 |
| Days to Decision | 283 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 |