# MXF: System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation

- Device class: 2; regulation: 21 CFR 872.4120; FDA's rule: 510(k) required
- FDA decisions: 5
- 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)
- 1999: 2
- 2002: 2
- 2003: 1

## Most-cited predicates
- K012511: Waterlase Millennium (2002), cited by 3
- K022803: Waterlase for Apicoectomy (2003), cited by 1
- K990219: Modification of Millennium (1999), cited by 1
- K013908: Waterlase Millennium (2002), cited by 1

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