Not currently registered with FDA under this name
North West Medical Instrument (Group) Co., Ltd.
Shanghai, China. Named as applicant on 2 dental 510(k) clearances between 2008 and 2010. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22008–2010
- Markets registered in
- 33 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name North West Medical Instrument (Group) 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 | Applicant | North West Medical Instrument (Group) Co., Ltd. | 2 clearances | 2008–2010 | Below |
| Taiwan | TFDA | Manufacturer | NORTHWEST MEDICAL INSTRUMENT(GROUP) CO., LTD. | 2 | 2006–2006 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Northwest Medical Instrument(Group)Co.,Ltd. | 1 | 2006–2006 | 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
510(k) clearances
Clearances on which FDA names North West Medical Instrument (Group) Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Apr 2010 | K093971 | DENTAL HANDPIECE | EFB Dental Air-Powered Handpiece |
| 4 Apr 2008 | K080438 | DENTAL UNIT WITH CHAIR | EIA Operative Dental Unit |
Some of these clearances are listed with FDA today by another company: Sinol Dental Limited (2).
Sources
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 of the most recent filing, which can be a US agent.