NPK

Barrier, Synthetic, Intraoral

Product code

NPK

Device name

Barrier, Synthetic, Intraoral

Device class

Class 2

21 CFR

21 CFR 872.3930

Medical specialty

Dental

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

31 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-12-08.

1 summaries are archived here for direct download.