Cleared Traditional

K232717 - Apex Locator (AL-Pex)

K232717 · Changzhou Haili Medical Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
108d
Days
-
Risk

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.

View all Changzhou Haili Medical Co., Ltd. devices

FDA 510(k) Submission Details - K232717

510(k) Number K232717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 127d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 19
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K232717.
Apex Locator
K242383 · Shenzhen Rogin Medical Co., Ltd. · Mar 2025
Electronic Apex Locator (Alpha Apex I)
K242765 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Jan 2025
Apex Locator
K231990 · Cefla S.C. · Feb 2024
Root Apex Locator
K212178 · Foshan Coxo Medical Instrument Co., Ltd. · Jul 2022
EQ-PEX
K210789 · Meta Systems Co., Ltd. · Oct 2021
BOMEDENT Apex locator, WISMY Apex locator
K203836 · Changzhou Bomedent Medical Technology Co.,Ltd · Mar 2021