Drill, Bone, Powered

What Is FDA Product Code DZI?

Drill, Bone, Powered is FDA product code DZI, Class 2, 21 CFR 872.4120.

How Does It Reach the US Market?

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 1 clearance under this code; the FDA took 164 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 20 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Packaging process control (13), Vendor change control (1) and Labeling design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.