K222741 is an FDA 510(k) clearance for the DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast). This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Hdi, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on November 7, 2022, 59 days after receiving the submission on September 9, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K222741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2022 |
| Decision Date | November 07, 2022 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |