Barrier, Animal Source, Intraoral

What Is It?

An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.

What Is FDA Product Code NPL?

Barrier, Animal Source, Intraoral is FDA product code NPL, Class 2, 21 CFR 872.3930.

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 2 clearances under this code; the FDA took a median of 277 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 11 recalls under this product code since 2012. None was by a company in China. The root causes the FDA records most often are Labeling mix-ups (6), Employee error (3) and Nonconforming Material/Component (1).

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