Data / Medical devices / China / Zhejiang Yinchili Medical Technology Co.,ltd
Zhejiang Yinchili Medical Technology Co.,ltd: FDA-registered device maker in Jiaxing City Zhejiang, China, 2 510(k) clearances
Zhejiang Yinchili Medical Technology Co.,ltd is registered with the FDA (registration 3015341209) in Jiaxing City Zhejiang, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 17, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015341209
- Address
- No. 999, Xingye Road, Daqiao Town, Nanhu District, Jiaxing City Zhejiang, China, 314006
- Owner or operator
- Zhejiang Yinchili Medical Technology Co.,Ltd (10060317)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 10, 2022
- Registered through
- 2026
- Brand names listed
- ClearCorrect System, Custom-made Invisible Aligners, REF04 ClearCorrect System Retainer, Clear Retainer (YCL-A-R, YCL-C-R), REF06 ClearCorrect System Engager Template
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| April 17, 2023 | K223454 | Custom-made Invisible Aligners | NXC | Substantially Equivalent | Zhejiang Yinchili Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 16, 2022 | K203624 | Custom-made Invisible Aligners | NXC | Substantially Equivalent | Zhejiang Yinchili Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Positioner, Tooth, Preformed
- All makers of Aligner, Sequential
- All makers of Indirect Bonding Tray
Updated April 17, 2023. 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.