Product code PEM

Device name

Dental Barriers And Sleeves

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4370

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.

Source

FDA openFDA device classification dataset