Product code OBR

Device name

Mouthguard, Over-The-Counter

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

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Source

FDA openFDA device classification dataset