PFL

Intraoral, Dental Foam Protector

Product code

PFL

Device name

Intraoral, Dental Foam Protector

Device class

Class 1

21 CFR

21 CFR 872.6890

Medical specialty

Dental

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

Intended to provide a soft barrier between wired mouth hardware and oral mucosa.

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