K250317 is an FDA 510(k) clearance for the EsFlow PLUS. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Spident Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on May 30, 2025, 115 days after receiving the submission on February 4, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K250317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2025 |
| Decision Date | May 30, 2025 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF - Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |