Cleared Traditional

Electronic Apex Locator (Alpha Apex I)

K242765 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Dental

Jan 2025

Decision

126d

Days

—

Risk

About This 510(k) Submission

K242765 is an FDA 510(k) clearance for the Electronic Apex Locator (Alpha Apex I), 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 review panel.

Submission Details

510(k) Number	K242765 FDA.gov
FDA Decision	Cleared 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