Product code NPK

Device name

Barrier, Synthetic, 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

A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.

Source

FDA openFDA device classification dataset