Manufacturer registered with FDA
Kuang Yeu Co. Ltd
Taichung, Taiwan. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 310 registrations outside the US
- Establishments
- 1Taiwan
Registered in 3 markets
Where regulators' registries name Kuang Yeu 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 | Kuang Yeu Co. Ltd | 3 device types | — | Below |
| South Korea | MFDS | Manufacturer | Kuang Yeu Medical Co., Ltd.Kuang Yeu Medical Co.,Ltd. | 6 | 2003–2003 | Pure Global AI |
| Australia | TGA | Manufacturer | Kuang Yeu Medical Co Ltd | 4 | 2012–2012 | 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 Kuang Yeu 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 Operating LightEAZ · Class 1 | Dental operating lights | Maker | Kuang Yeu | 2009 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Kuang Yeu | 2009 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Kuang Yeu | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Kuang Yeu Co. Ltd lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Tpc Advanced Technology, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Aug 2007 | K071485 | TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 | Tpc Advanced Technology, Inc. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Kuang Yeu Medical Co., Ltd.FDA reg. 3006766059 | Taichung City, TAIWAN, Taiwan | Manufacturer |
Other names on FDA records
Kuang Yeu Medical Co.,Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024042). 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.