Oral Wound Dressing
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Guangdong: 2 hold an FDA registration.
- Huizhou Foryou Medical Devices Co., Ltd. Guangdong, contract manufacturer
- Shenzhen JPY ION-Tech. Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
What Is FDA Product Code OLR?
Oral Wound Dressing is FDA product code OLR, 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 1 clearance under this code; the FDA took 114 days from receipt to decision.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2022. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.