K240304 is an FDA 510(k) clearance for the Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5). This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).
Submitted by Enpuno Biotechnology Co., Ltd. (Changsha High-Tech Development Zone Chan, CN). The FDA issued a Cleared decision on May 28, 2024, 116 days after receiving the submission on February 2, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K240304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2024 |
| Decision Date | May 28, 2024 |
| Days to Decision | 116 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 |