PME

External Cleaning Solution

Product code

PME

Device name

External Cleaning Solution

Device class

Class 2

21 CFR

21 CFR 872.3260

Medical specialty

Dental

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

For use on dental restorations, external to the mouth, prior to insertion into the mouth.

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