K213339 is an FDA 510(k) clearance for the DENU Composite Resin, DENU Flow Resin. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Hdi, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 23, 2022, 351 days after receiving the submission on October 7, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K213339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2021 |
| Decision Date | September 23, 2022 |
| Days to Decision | 351 days |
| Submission Type | Abbreviated |
| 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 |