Teeth Screw Driver
A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent…
Screw, Oral
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Shanghai. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Flexicare Medical (Dongguan) Ltd. Guangdong, contract manufacturer
- MDF Instruments Medifriend Inc. Shanghai
What Is FDA Product Code KBW?
Screw, Oral is FDA product code KBW, Class 1, 21 CFR 874.4420.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2010. None was by a company in China. The root cause the FDA records most often is Mixed-up of materials/components (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.