Data / Medical devices / China / Changzhou Bomedent Medical Technology Co., Ltd
Changzhou Bomedent Medical Technology Co., Ltd: FDA-registered device maker in Changzhou Jiangsu, China, 3 510(k) clearances
Changzhou Bomedent Medical Technology Co., Ltd is registered with the FDA (registration 3017618678) in Changzhou Jiangsu, China. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 8, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017618678
- Address
- NO.9 Changyang road, West Taihu Science Techology Industrial Park, Changzhou Jiangsu, China, 213100
- Owner or operator
- ChangZhou BoMedent Medical Technology Co., Ltd (10078266)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 16, 2020
- Registered through
- 2026
- Brand names listed
- BOMEDENT Apex locator, WISMY Apex locator, Dental Electrical Motor iRoot Pro, Endodontic Obturation Devices, SCM-019, iBon, iBon Mini, iBon Mini-SE, Ultrasonic Endo Activation Device (Model: Actor I pro)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Cutting, Operative | EKD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Locator, Root Apex | LQY | U | Manufacturer | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Manufacturer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2022 | K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | ELC | Substantially Equivalent | Changzhou Bomedent Medical Technology Co.,Ltd | accessdata.fda.gov |
| March 30, 2021 | K203836 | BOMEDENT Apex locator, WISMY Apex locator | LQY | Substantially Equivalent | Changzhou Bomedent Medical Technology Co.,Ltd | accessdata.fda.gov |
| June 30, 2020 | K191276 | Dental Electrical Motor iRoot Pro | EKX | Substantially Equivalent | Changzhou Bomedent Medical Technology Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Scaler, Ultrasonic
- All makers of Instrument, Filling, Plastic, Dental
- All makers of Locator, Root Apex
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Preparer, Root Canal Endodontic
- All makers of Instrument, Cutting, Operative
Updated September 8, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.