FDA Product Code OBR: Mouthguard, Over-the-counter
To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.
Leading manufacturers include Doc Brands, Inc., Remi and Encore Guards.
FDA 510(k) Cleared Mouthguard, Over-the-counter Devices (Product Code OBR)
About Product Code OBR - Regulatory Context
510(k) Submission Activity
45 total 510(k) submissions under product code OBR since 2006, with 45 receiving FDA clearance (average review time: 133 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA Review Time
FDA review times for OBR submissions have been consistent, averaging 143 days recently vs 132 days historically.
OBR devices are reviewed by the Dental panel. Browse all Dental devices →