# JXL: Block, Bite

- Device class: 2; regulation: 21 CFR 882.5070; FDA's rule: 510(k) required
- FDA decisions: 28
- 510(k) review time 2021–2025: median 332 days (middle half 305–358)
- 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)
- 1992: 1
- 1993: 2
- 1995: 1
- 1996: 2
- 1999: 1
- 2005: 1
- 2015: 1
- 2017: 1
- 2021: 1
- 2023: 1

## Most-cited predicates
- K992269: Ventil-a Oral Protector (1999), cited by 4
- K954352: Bite Block (1996), cited by 1
- K864181: Somatics Mouth Guard (Bite Block) (1986), cited by 1
- K924304: Bite Block (1993), cited by 1
- K172978: SurgeoBite (2017), cited by 1
- K050188: Epiguard (2005), cited by 1

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