K232717 - Apex Locator (AL-Pex), Apex Locator (AL-Pex+) (FDA 510(k) Clearance)

K232717 is an FDA 510(k) clearance for the Apex Locator (AL-Pex), Apex Locator (AL-Pex+). Classified as Locator, Root Apex (product code LQY).

Submitted by Changzhou Haili Medical Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on December 22, 2023 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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