Data / Medical devices / Material, Impression / China
FDA-registered makers of Material, Impression in China: 6 establishments
6 establishments in China are registered with the FDA to make Material, Impression (product code ELW). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Material, Impression
- Product code
- ELW
- Country
- China
Makers of Material, Impression in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hygedent Inc. | Beijing, China | Contract manufacturer, Exporter to the US, Manufacturer | 4 | April 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shandong Huge Dental Material Corporation | Rizhao Shandong, China | Manufacturer | 2 | September 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Chemoment Materials Co.,ltd | Hefei Anhui, China | Exporter to the US, Manufacturer | 1 | August 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Jiangxi Dentalbright Technology Co., Ltd | Jiujiang City Jiangxi, China | Exporter to the US, Manufacturer | 1 | July 28, 2021 | 0 | 0 | 0 | api.fda.gov |
| Sunrise Dental Laboratory, Ltd. | Kowloon, Hong Kong, China | Exporter to the US, Manufacturer | 1 | April 3, 2003 | 0 | 0 | 0 | api.fda.gov |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou Henan, China | Exporter to the US, Manufacturer | 1 | October 8, 2020 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.