K242765 is an FDA 510(k) clearance for the Electronic Apex Locator (Alpha Apex I). This device is classified as a Locator, Root Apex.
Submitted by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. (Shenzhen, CN). The FDA issued a Cleared decision on January 17, 2025, 126 days after receiving the submission on September 13, 2024.
This device falls under the Dental FDA review panel.
| 510(k) Number | K242765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2024 |
| Decision Date | January 17, 2025 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LQY - Locator, Root Apex |
| Device Class | - |