# OBR: Mouthguard, Over-The-Counter

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 131 days (middle half 95–151)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 1
- 2018: 2
- 2019: 3
- 2020: 3
- 2021: 2
- 2022: 2
- 2023: 1
- 2024: 2
- 2025: 3
- 2026: 4

## Most-cited predicates
- K072147: Den Tek Comfort Fit Nightguard (2007), cited by 6
- K091792: Rest Assured Generation II Dental Protector (2009), cited by 4
- K091660: Custom Comfort Nightguard Version 2 (2009), cited by 4
- K121272: Protech Dent (2012), cited by 3
- K073220: The Doctor's Nightguard Advanced Comfort (2007), cited by 3
- K100545: Sleepright (2010), cited by 2
- K193577: SleepRight ProRx Custom Dental Guard (2020), cited by 2
- K221369: FBCC Night Guard (2022), cited by 2
- K181099: Bright Guard (2019), cited by 2
- K091175: Grind NO More Version 2 and 3 (2009), cited by 2

Source page: https://510kreport.com/product-code/OBR
Data by year (CSV): https://510kreport.com/product-code/OBR.csv