Manufacturer registered with FDA
Foshan ORECK Medical Technology Co.,Ltd
Foshan City, 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
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Foshan ORECK 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 | Foshan ORECK Medical Technology Co.,Ltd | 2 device types | — | Below |
| Brazil | ANVISA | Manufacturer | FOSHAN ORECK MEDICAL TECHNOLOGY CO. LTD. | 1 | 2026–2026 | 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 Foshan ORECK 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 |
|---|---|---|---|---|
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | Root canal enlarger (Gates drills, Pesso reamers, Fiber post drills) | 2026 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Root canal file, Endodontic file | 2026 |
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 |
|---|---|---|
| FOSHAN ORECK MEDICAL TECHNOLOGY CO.,LTDFDA reg. 3043655586 | Foshan City Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095032). 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.