# JES: Floss, Dental

- Device class: 1; regulation: 21 CFR 872.6390; FDA's rule: 510(k) exempt
- FDA decisions: 62
- 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)
- 1989: 1
- 1990: 3
- 1991: 5
- 1992: 1
- 1993: 3
- 1994: 2
- 1995: 7
- 1996: 1
- 1997: 1
- 2009: 1

## Most-cited predicates
- K935440: Johnson & Johnson Fluoride Dental Floss, Mint Waxed (1994), cited by 2
- K925409: Oral-B Dental Floss with Fluoride (1993), cited by 2
- K925408: Oral-B Dental Tape with Fluoride (1993), cited by 1
- K952091: Vutler G.U.M. with Fluoride (1995), cited by 1

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