Abutment, Implant, Dental, Endosseous

What Is It?

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

What Is FDA Product Code NHA?

Abutment, Implant, Dental, Endosseous is FDA product code NHA, Class 2, 21 CFR 872.3630.

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. Chinese applicants hold 3 clearances under this code; the FDA took a median of 354 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 225 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Packaging (91), Process control (51) and Employee error (41).

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