K233954 is an FDA 510(k) clearance for the Chemi-SiL (HB, MB, LB, LBS). This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by B&E Korea Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on February 13, 2024, 60 days after receiving the submission on December 15, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K233954 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2023 |
| Decision Date | February 13, 2024 |
| Days to Decision | 60 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 |