# EIE: Dam, Rubber

- Device class: 1; regulation: 21 CFR 872.6300; FDA's rule: 510(k) exempt
- FDA decisions: 33
- 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)
- 1994: 1
- 1995: 1
- 1996: 2
- 1998: 2
- 2001: 1
- 2002: 3
- 2004: 1
- 2005: 2
- 2016: 1
- 2019: 1

## Most-cited predicates
- K010935: Britesmile Barrier Material (2001), cited by 1
- K151945: Triumph Resin Dam (2016), cited by 1
- K972775: Fastdam (1998), cited by 1

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