K241226 is an FDA 510(k) clearance for the Fixtemp® C&B 4:1. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Dreve Denatmid GmbH (Nordrhein-Westfalen, DE). The FDA issued a Cleared decision on May 31, 2024, 29 days after receiving the submission on May 2, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K241226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2024 |
| Decision Date | May 31, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG - Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |