OBR

Mouthguard, Over-The-Counter

Product code

OBR

Device name

Mouthguard, Over-The-Counter

Device class

Class U

Medical specialty

Unknown

Marketing pathway

510(K)

510(k) clearances (last 3 years)

9

Summaries archived here

8 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

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

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

510(k) clearances, last 3 years (9)

Last three years. Most recent: 2026-06-25.

8 summaries are archived here for direct download.