Implant, Endosseous, Root-Form

What Is FDA Product Code DZE?

Implant, Endosseous, Root-Form is FDA product code DZE, Class 2, 21 CFR 872.3640.

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 8 clearances under this code; the FDA took a median of 347 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 212 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (34), Packaging (30) and Labeling Change Control (23).

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