K243910 is an FDA 510(k) clearance for the Retraxil. This device is classified as a Cord, Retraction.
Submitted by Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on September 24, 2025, 279 days after receiving the submission on December 19, 2024.
This device falls under the Dental FDA review panel.
| 510(k) Number | K243910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2024 |
| Decision Date | September 24, 2025 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MVL — Cord, Retraction |
| Device Class | — |