Product code PME

Device name

External Cleaning Solution

Medical specialty

Dental

Device class

2

Regulation number

872.3260

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

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

Source

FDA openFDA device classification dataset