PEM

Dental Barriers And Sleeves

Product code

PEM

Device name

Dental Barriers And Sleeves

Device class

Class 2

21 CFR

21 CFR 878.4370

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

15

FDA classification definition

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

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

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2025-06-10.

3 summaries are archived here for direct download.