FDA · official record K242765Substantially Equivalent

Electronic Apex Locator (Alpha Apex I)

Name: Electronic Apex Locator (Alpha Apex I) — FDA K242765
Creator: SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Keywords: Electronic Apex Locator (Alpha Apex I), Electronic Apex Locator (Alpha Apex I), K242765, LQY, FDA

United StatesLQYSHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

Verified

Official record identity

FDA application number: K242765
Decision date: January 17, 2025
Published decision: Substantially Equivalent

Classification

Product code: LQY

Published parties

Applicant: SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2024-09-13
Review panel: Unknown
Current product-code class (harmonized): U

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.