K243356 is an FDA 510(k) clearance for the Asiga DentaBASE. This device is classified as a Resin, Denture, Relining, Repairing, Rebasing (Class II - Special Controls, product code EBI).
Submitted by Asiga Pty, Ltd. (Alexandria, AU). The FDA issued a Cleared decision on April 11, 2025, 164 days after receiving the submission on October 29, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3760.
| 510(k) Number | K243356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2024 |
| Decision Date | April 11, 2025 |
| Days to Decision | 164 days |
| Submission Type | Abbreviated |
| 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 |