Manufacturer registered with FDA
ChangZhou BoMedent Medical Technology Co., Ltd
Changzhou, China. Lists 5 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 22020–2022
- Markets registered in
- 824 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name ChangZhou BoMedent Medical Technology Co., Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | ChangZhou BoMedent Medical Technology Co., Ltd | 2 clearances | 2020–2022 | Below |
| European Union | EUDAMED | Manufacturer | ChangZhou BoMedent Medical Technology Co., Ltd. | 6 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD. | 5 | 2023–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | ChangZhou BoMedent Medical Technology Co Ltd | 4 | 2024–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Changzhou BOMEDENT Medical Technology Co., Ltd | 3 | 2018–2019 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD. | 2 | 2025–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | ChangZhou BoMedent Medical Technology Co., Ltd. | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | ChangZhou BoMedent Medical Technology Co Ltd | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What ChangZhou BoMedent Medical Technology Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Endodontic Obturation Devices | 2021 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | Endodontic Obturation Devices | 2021 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | SCM-019, iBon, iBon Mini, iBon Mini-SE | 2023 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Dental Electrical Motor iRoot Pro | 2020 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Ultrasonic Endo Activation Device (Model: Actor I pro) | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names ChangZhou BoMedent Medical Technology Co., Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Sep 2022 | K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | ELC Ultrasonic Scaler |
| 30 Jun 2020 | K191276 | Dental Electrical Motor iRoot Pro | EKX Ac-Powered Direct Drive Handpiece |
Some of these clearances are listed with FDA today by another company: Beyes Dental Inc (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTDFDA reg. 3017618678 | Changzhou Jiangsu, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10078266). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.