Data / Medical devices / Taiwan / Ze Fang Technology Co., Ltd.
Ze Fang Technology Co., Ltd.: FDA-registered device maker in Taichung, Taiwan, 1 510(k) clearance
Ze Fang Technology Co., Ltd. is registered with the FDA (registration 3013689189) in Taichung, Taiwan. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013689189
- Address
- 1F, No.17, Aly. 81, Ln. 2, Sec.1 Zhongxing Rd., Dali Dist., Taichung Taichung - District, TAIWAN (CHINA) 412, Taichung, Taiwan, 412
- Owner or operator
- ZE FANG TECHNOLOGY CO., LTD. (10062228)
- Roles
- Manufacturer
- First device listed
- December 30, 2019
- Registered through
- 2026
- Brand names listed
- 3D Self-ligating Bracket-M002200, 3D Self-ligating Bracket-M002200H, 3D Self-ligating Bracket-M002200L, 3D Self-ligating Bracket-M002200M, 3D Self-ligating Bracket-M002200R, 3D Self-ligating Bracket-M002200S, 3D Self-ligating Bracket-M002211, 3D Self-ligating Bracket-M002211H and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 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 |
|---|---|---|---|---|---|---|
| October 7, 2022 | K202163 | Mico One Orthodontic Screw | OAT | Substantially Equivalent | Ze Fang Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Clamp, Wire, Orthodontic
- All makers of Implant, Endosseous, Orthodontic
- All makers of Spring, Orthodontic
- All makers of File, Pulp Canal, Endodontic
- All makers of Wire, Orthodontic
- All makers of Bracket, Metal, Orthodontic
Updated October 7, 2022. 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.