Data / Medical devices / China / Zhongshan Miiyen New Material Technology Co., Ltd
Zhongshan Miiyen New Material Technology Co., Ltd: FDA-registered device maker in Zhongshan Guangdong, China, 3 510(k) clearances
Zhongshan Miiyen New Material Technology Co., Ltd is registered with the FDA (registration 3027481489) in Zhongshan Guangdong, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 31, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3027481489
- Address
- Unit 8, 2nd Floor, E Building, 104 Qihao Road, Torch Development Disctict, Zhongshan Guangdong, China, 528437
- Owner or operator
- ZHONGSHAN MIIYEN NEW MATERIAL TECHNOLOGY CO., LTD (10094371)
- Roles
- Exporter to the US
- First device listed
- November 25, 2025
- Registered through
- 2026
- Brand names listed
- Cobalt-Chromium alloy powder, model: KND/CW-LP, Dental Ceramic, Dental Co-Cr framework alloy, model: KND/CW-H, Dental Co-Cr porcelain alloy, model: KND/CW-CC, Dental Lithium Disilicate Glass-Ceramic, Dental Ni-Cr porcelain alloy, model: KND/CW-NP, Dental Porcelain, Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Metal, Base | EJH | 2 | Exporter to the US | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Exporter to the US | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Exporter to the US | 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 31, 2024 | K240912 | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) | EIH | Substantially Equivalent | Anhui Miisen Intelligence Technology Co., Ltd. | accessdata.fda.gov |
| July 3, 2023 | K230487 | Dental Lithium Disilicate Glass-Ceramic | EIH | Substantially Equivalent | Fuzhou Rick Brown Biomaterials Co., Ltd. | accessdata.fda.gov |
| May 22, 2019 | K182350 | Dental Ceramic | EIH | Substantially Equivalent | Baot Biological Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of Alloy, Metal, Base
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Updated May 31, 2024. 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.