Product code OLR

Device name

Oral Wound Dressing

Medical specialty

Unknown

Device class

U

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Source

FDA openFDA device classification dataset