Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) — Enpuno Biotechnology Co., Ltd. (510(k) K
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) — Enpuno Biotechnology Co., Ltd. (510(k) K is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5); Applicant:
| Device name | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) |
|---|---|
| Applicant | Enpuno Biotechnology Co., Ltd. |
| Clearance track | 510(k) |
| Submission number | K240304 |
| Decision | Substantially Equivalent |
| Decision date | 2024-05-28 |
| Date received | 2024-02-02 |
| Product code | KIF |
| Device class | 2 |
| Medical specialty | Dental |
| Applicant location | CN |
| Source | openFDA device |
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$1999/mo
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