BOMEDENT Apex locator, WISMY Apex locator— 510(k) K203836

Name: FDA 510(k) clearance K203836
Creator: U.S. Food and Drug Administration
Published: 2021-03-30

Substantially Equivalent

Changzhou Bomedent Medical Technology Co.,Ltd

FDA 510(k) clearance K203836 for BOMEDENT Apex locator, WISMY Apex locator, Substantially Equivalent on 2021-03-30. Applicant: Changzhou Bomedent Medical Technology Co.,Ltd. Device class: Unclassified.

Clearance details

Applicant: Changzhou Bomedent Medical Technology Co.,Ltd
Product code: Code LQY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2020-12-30
Decision date: 2021-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LQY

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K252224 — Apex Locator (FindPex)2026-04-08
K242383 — Apex Locator2025-03-07
K242765 — Electronic Apex Locator (Alpha Apex I)2025-01-17
K231990 — Apex Locator2024-02-13
K232717 — Apex Locator (AL-Pex), Apex Locator (AL-Pex+)2023-12-22

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Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.