K232717 is an FDA 510(k) clearance for the Apex Locator (AL-Pex), Apex Locator (AL-Pex+). This device is classified as a Locator, Root Apex.
Submitted by Changzhou Haili Medical Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on December 22, 2023, 108 days after receiving the submission on September 5, 2023.
This device falls under the Dental FDA review panel.
| 510(k) Number | K232717 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2023 |
| Decision Date | December 22, 2023 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LQY - Locator, Root Apex |
| Device Class | - |