# EFS: Unit, Oral Irrigation

- Device class: 1; regulation: 21 CFR 872.6510; FDA's rule: 510(k) exempt
- FDA decisions: 47
- 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)
- 1990: 6
- 1991: 5
- 1992: 3
- 1993: 1
- 1994: 3
- 1995: 1
- 1997: 1
- 1998: 1
- 2000: 1
- 2002: 1

## Most-cited predicates
- K904850: Dual and Single Irr. Systems Models 29550 & 29555 (1991), cited by 1
- K952234: Barrier All Film (1995), cited by 1
- K001493: Dental Air Force Home Dental Cleaning System, Model NO. 0020001 (2000), cited by 1

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