Registered with FDA
Zhongshan Miiyen New Material Technology Co., Ltd.
Zhongshan, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 22
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Zhongshan Miiyen New Material Technology Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | Dental CeramicDental Lithium Disilicate Glass-CeramicDental PorcelainDental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)Formative LiquidPowder, PorcelainPress Ceramic | 2025 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Lister | Cobalt-Chromium alloy powder, model: KND/CW-LPDental Co-Cr framework alloy, model: KND/CW-HDental Co-Cr porcelain alloy, model: KND/CW-CCDental Ni-Cr porcelain alloy, model: KND/CW-NPTitanium alloy powder, model: KND/CW-TP | 2025 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | ELETRA SMARTIntraoral Digital Impression InstrumentPANDA FreePANDA P2PANDA P2 PlusPANDA P3PANDA P3 PlusPANDA Smart PPANDA Smart YPIOS-EX5 | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Zhongshan Miiyen New Material Technology Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Anhui Miisen Intelligence Technology Co., Ltd. (1), Fuzhou Rick Brown Biomaterials Co. Ltd. (1), Baot Biological Technology Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 May 2024 | K240912 | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) | Anhui Miisen Intelligence Technology Co., Ltd. | EIH Porcelain Powder |
| 3 Jul 2023 | K230487 | Dental Lithium Disilicate Glass-Ceramic | Fuzhou Rick Brown Biomaterials Co. Ltd. | EIH Porcelain Powder |
| 22 May 2019 | K182350 | Dental Ceramic | Baot Biological Technology Co., Ltd. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ZHONGSHAN MIIYEN NEW MATERIAL TECHNOLOGY CO., LTDFDA reg. 3027481489 | Zhongshan Guangdong, China | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094371). 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.