DeviceClearance

Product code OBR— Unknown

SleepRight ProRx Custom Dental Guard

Classification name
Mouthguard, Over-The-Counter
Device class
Unclassified
Advisory panel
Unknown
Total cleared
46
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OBR, via openFDA

Market context for product code OBR

FDA has cleared 46 devices under product code OBR between 2006 and 2026, filed by 31 applicant companies. No FDA device recalls reference this product code.

Clearances per year

last 15 years

Top applicants under product code OBR

Recent clearances under product code OBR

Data sourced from openFDA. This site is unofficial and independent of the FDA.