# K203836: BOMEDENT Apex locator, WISMY Apex locator

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Bomedent Medical Technology Co.,Ltd
- Decided: Mar 30, 2021 after 90 days
- Product code: LQY (Locator, Root Apex)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K992233 (1999). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191806: Propex IQ Apex Locator, Dentsply Sirona (2019) Summary page 4.

## Most influential descendants
- K232717: Apex Locator (AL-Pex), Apex Locator (AL-Pex+) (2023), 1 descendant of its own
- K212178: Root Apex Locator (2022), 1 descendant of its own
- K242383: Apex Locator (2025), 0 descendants of its own
- K242765: Electronic Apex Locator (Alpha Apex I) (2025), 0 descendants of its own

## Indications for use
BOMEDENT Apex locator and WISMY Apex locator support the dentist in the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

Source page: https://510kreport.com/device/K203836
Methodology: https://510kreport.com/methodology