Data / Medical devices / China / Foshan Wenjian Medical Instrument Co., Ltd.
Foshan Wenjian Medical Instrument Co., Ltd.: FDA-registered device maker in Foshan Guangdong, China, 1 510(k) clearance
Foshan Wenjian Medical Instrument Co., Ltd. is registered with the FDA (registration 3017619674) in Foshan Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 26, 2020. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017619674
- Address
- Block A, Sanyi logistics zone, Luocun, Foshan Guangdong, China, 528226
- Owner or operator
- Foshan Wenjian Medical Instrument Co., Ltd. (10078430)
- Roles
- Manufacturer
- First device listed
- October 22, 2020
- Registered through
- 2026
- Brand names listed
- High-speed air turbine handpiece (model: WJ-114, WJ- 112, WJ-124, WJ -122, WJ- 134, WJ -132, WJ - 144), High-speed air turbine handpiece (model: WJ-142, WJ-154, WJ-152, WJ-164, WJ-162), Low-speed air turbine handpiece (WJ-414, WJ-412, WJ-424, WJ-422)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 26, 2020 | K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | EFB | Substantially Equivalent | Foshan Wenjian Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Air-Powered, Dental
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
Updated May 26, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.