Data / Medical devices / Mouthguard, Prescription / China
FDA-registered makers of Mouthguard, Prescription in China: 6 establishments
6 establishments in China are registered with the FDA to make Mouthguard, Prescription (product code MQC). 3 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
- Mouthguard, Prescription
- Product code
- MQC
- Country
- China
Makers of Mouthguard, Prescription in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aidite (qinhuangdao) Technology Co., Ltd | Qinhuangdao City Hebei, China | Manufacturer | 1 | October 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Heygears Imc.inc | Guangzhou Guangdong, China | Specification developer | 1 | March 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shandong Huge Dental Material Corporation | Rizhao Shandong, China | Manufacturer | 1 | August 1, 2025 | 0 | 0 | 0 | api.fda.gov |
| Huliang (shanghai) Bio-Tech Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Heygears Innovative Material Co., Ltd | Jiujiang Jiangxi, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Sezen Technology Co., Ltd. | Ningbo Zhejiang, 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.