K242383 is an FDA 510(k) clearance for the Apex Locator. This device is classified as a Locator, Root Apex.
Submitted by Shenzhen Rogin Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 7, 2025, 207 days after receiving the submission on August 12, 2024.
This device falls under the Dental FDA review panel.
| 510(k) Number | K242383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2024 |
| Decision Date | March 07, 2025 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LQY — Locator, Root Apex |
| Device Class | — |