# Changzhou Bomedent Medical Technology Co.,Ltd

- Location (FDA's records): Changzhou, CN
- FDA decisions: 3 (2020–2022): 3 510(k) clearances
- Product codes: ELC (1), EKX (1), LQY (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Schlumbohm GmbH & Co. KG: 1 (https://510kreport.com/company/schlumbohm)
- J. Morita USA, Inc.: 1 (https://510kreport.com/company/j-morita-usa)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)

## Firms that cite its devices most
- Foshan Coxo Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/foshan-coxo-medical-instrument)
- Changzhou Haili Medical Co., Ltd.: 1 (https://510kreport.com/company/changzhou-haili-medical)

## Its most-cited devices
- K203836: BOMEDENT Apex locator, WISMY Apex locator (2021), cited by 2

## Recent decisions
- K213947: Ultrasonic Endo Activation Device (Model:Actor I pro) (Sep 8, 2022)
- K203836: BOMEDENT Apex locator, WISMY Apex locator (Mar 30, 2021)
- K191276: Dental Electrical Motor iRoot Pro (Jun 30, 2020)

Source page: https://510kreport.com/company/changzhou-bomedent-medical-technology