Product code NPL

Device name

Barrier, Animal Source, Intraoral

Medical specialty

Dental

Device class

2

Regulation number

872.3930

Review panel

DE

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

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.

Source

FDA openFDA device classification dataset