What Is FDA Product Code NDP?
Accessories, Implant, Dental, Endosseous is FDA product code NDP, Class 1, 21 CFR 872.3980.
How Does It Reach the US Market?
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 57 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Process control (10), Packaging process control (10) and Process change control (7).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.