510(k) Report

FDA applicant

Changzhou Bomedent Medical Technology Co.,Ltd

Changzhou, CN3 decisions2020–20220 recalls

FDA records 3 decisions for Changzhou Bomedent Medical Technology Co.,Ltd (Changzhou, CN) from 2020 to 2022: 3 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and EKX (Handpiece, Direct Drive, Ac-Powered). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Changzhou Bomedent Medical Technology Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020: 12021: 12022: 1
2020high 1 (2020) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Changzhou Bomedent Medical Technology Co.,Ltd by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ELCScaler, Ultrasonic1decision
  • EKXHandpiece, Direct Drive, Ac-Powered1decision
  • LQYLocator, Root Apex1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203836BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd · 20212cite it

What has FDA decided for it lately?

  • K213947Ultrasonic Endo Activation Device (Model:Actor I pro)Changzhou Bomedent Medical Technology Co.,Ltd · 2022
  • K203836BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd · 2021
  • K191276Dental Electrical Motor iRoot ProChangzhou Bomedent Medical Technology Co.,Ltd · 2020

All 3 as Changzhou Bomedent Medical Technology Co.,Ltd →