K241131 is an FDA 510(k) clearance for the edelweiss CAD/CAM T-BLOCK. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Edelweiss Dentistry Products GmbH (Wolfurt, AT). The FDA issued a Cleared decision on October 18, 2024, 177 days after receiving the submission on April 24, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K241131 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2024 |
| Decision Date | October 18, 2024 |
| Days to Decision | 177 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 |