K230410 is an FDA 510(k) clearance for the DD medical polymers (PMMA). This device is classified as a Resin, Denture, Relining, Repairing, Rebasing (Class II - Special Controls, product code EBI).
Submitted by Dental Direkt GmbH (Spenge, DE). The FDA issued a Cleared decision on June 23, 2023, 128 days after receiving the submission on February 15, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3760.
| 510(k) Number | K230410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2023 |
| Decision Date | June 23, 2023 |
| Days to Decision | 128 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBI - Resin, Denture, Relining, Repairing, Rebasing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3760 |