Mouthguard, Prescription
Who Makes This Device Type in China?
6 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Hebei and Hunan, and 3 other provinces. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Aidite (Qinhuangdao) Technology Co., Ltd. Hebei
- Guangzhou Heygears Imc.inc Guangdong
- Hunan Vsmile Biotechnology Co., Ltd. Hunan, contract manufacturer
- Huliang (shanghai) Bio-Tech Co., Ltd. Shanghai
- Ningbo Sezen Technology Co., Ltd. Zhejiang, contract manufacturer
- Shandong Huge Dental Material Corporation Shandong
How Is MQC Classified?
Mouthguard, Prescription is FDA product code MQC, unclassified.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 3 clearances under this code; the FDA took a median of 100 days from receipt to decision on them.
What Do the Recalls Say?
The FDA has recorded 2 recalls under this product code since 2021. None was by a company in China. The root causes the FDA records most often are Labeling mix-ups (1) and Process control (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.