Electronic Apex Locator (Alpha Apex I)— 510(k) K242765

Substantially Equivalent

SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

FDA 510(k) clearance K242765 for Electronic Apex Locator (Alpha Apex I), Substantially Equivalent on 2025-01-17. Applicant: SHENZHEN SUPERLINE TECHNOLOGY CO., LTD..

Clearance details

Applicant: SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Product code: Code LQY
Advisory panel: Unknown
Date received: 2024-09-13
Decision date: 2025-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.