Data / Medical devices / Dental Barriers And Sleeves / China
FDA-registered makers of Dental Barriers And Sleeves in China: 11 establishments
11 establishments in China are registered with the FDA to make Dental Barriers And Sleeves (product code PEM). 10 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
- Dental Barriers And Sleeves
- Product code
- PEM
- Country
- China
Makers of Dental Barriers And Sleeves in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Yueying Medical Instruments (langfang) Co., Ltd. | Langfang City Hebei, China | Exporter to the US, Manufacturer | 2 | May 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| BH Medical Products Co., Ltd | Changzhou City Jiangsu, China | Manufacturer | 1 | September 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Dongguan Wanjin Industrial Co., Ltd | DongGuang Guangdong, China | Manufacturer | 1 | June 14, 2019 | 0 | 0 | 0 | api.fda.gov |
| Fomed Industries Inc | Qian Jiang Hubei, China | Manufacturer | 1 | June 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Premium Plus (dongguan) Limited | Dongguan Guangdong, China | Manufacturer | 1 | May 11, 2022 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Pac-Dent Technology Co., Ltd | SUZHOU CITY Jiangsu, China | Contract manufacturer, Manufacturer | 1 | June 7, 2016 | 0 | 0 | 0 | api.fda.gov |
| Tianjin Water Source Tech Co., Ltd. | Tianjin, China | Manufacturer | 1 | December 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| Wellmed Dental Medical Supply Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | October 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Yongqing Huaguan Dental Instruments Factory | Langfang City Hebei, China | Exporter to the US, Manufacturer | 1 | May 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| iBrite Suzhou Technology Co., Ltd | SUZHOU CITY Jiangsu, China | Manufacturer | 1 | March 3, 2016 | 0 | 0 | 0 | api.fda.gov |
| Jinyuan Medical Equipment(tianjin)co.,ltd | Tianjin, China | Contract manufacturer | 0 | 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.