K240823 is an FDA 510(k) clearance for the els extra low shrinkage® composite & els extra low shrinkage® flow. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Saremco Dental AG (Rebstein, CH). The FDA issued a Cleared decision on June 27, 2024, 93 days after receiving the submission on March 26, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K240823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2024 |
| Decision Date | June 27, 2024 |
| Days to Decision | 93 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 |