Cleared Traditional

Apex Locator (AL-Pex), Apex Locator (AL-Pex+)

K232717 · Changzhou Haili Medical Co., Ltd. · Dental

Dec 2023

Decision

108d

Days

—

Risk

About This 510(k) Submission

K232717 is an FDA 510(k) clearance for the Apex Locator (AL-Pex), Apex Locator (AL-Pex+), 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 review panel.

Submission Details

510(k) Number	K232717 FDA.gov
FDA Decision	Cleared 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