# DYX: Lock, Wire, And Ligature, Intraoral

- Device class: 2; regulation: 21 CFR 872.4600; FDA's rule: 510(k) required
- FDA decisions: 11
- 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)
- 1982: 1
- 1986: 1
- 1991: 1
- 1993: 2
- 1999: 2
- 2003: 2
- 2006: 1
- 2017: 1

## Most-cited predicates
- K820944: Dental Arch Bar (1982), cited by 4
- K061271: Erch Arch Bar, Model 38-690-00 (2006), cited by 3
- K991004: Synthes Quick Lock Imf System (1999), cited by 2
- K030605: Rapid Imf (2003), cited by 1
- K031207: Safety Release Arch Bar Kit (2003), cited by 1
- K910090: Dimac Wires (1991), cited by 1

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