# MQC: Mouthguard, Prescription

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 72
- 510(k) review time 2021–2025: median 179 days (middle half 100–261)
- Recalls: 1 (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)
- 2015: 3
- 2017: 2
- 2019: 5
- 2020: 4
- 2021: 7
- 2022: 5
- 2023: 6
- 2024: 8
- 2025: 4
- 2026: 2

## Most-cited predicates
- K183598: KeyPrint KeySplint Soft (2019), cited by 11
- K071404: Sleep Right - Select, Low Profile and Advance (2007), cited by 9
- K053580: Doctor's Nightguard (2006), cited by 8
- K022809: EZ Splint & EZ Splint PM (2003), cited by 6
- K014079: DR. Hays Bite Guard (2002), cited by 5
- K203000: KeyPrint KeySplint Hard (2021), cited by 5
- K063483: Den Tek Nightguard (2007), cited by 4
- K102909: Somnobrux Splints (2011), cited by 3
- K111066: Migra Tab, Quicksplint Migraine (2011), cited by 3
- K062828: Mouthguard and Aligner Materials (2006), cited by 3

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