Manufacturer registered with FDA
Jung Chen Technology Co., Ltd
Zhuhai, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Jung Chen 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 | Jung Chen Technology Co., Ltd | 2 device types | — | Below |
| South Korea | MFDS | Manufacturer | Jung Chen Technology Co., LtdJungchen Technology Co., Ltd. | 2 | 2011–2024 | 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 Jung Chen 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 |
|---|---|---|---|---|
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Disposable Prophy Angle | 2009 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | AeroPro Cordless Prophy System | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| JUNG CHEN TECHNOLOGY CO., LTD.FDA reg. 3008544850 | Zhuhai Guangdong, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10030552). 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.