# KIH: Dispenser, Cement

- Device class: 1; regulation: 21 CFR 888.4200; FDA's rule: 510(k) exempt
- FDA decisions: 11
- Recalls: 2 (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)
- 1978: 2
- 1979: 1
- 1980: 1
- 1981: 1
- 1983: 1
- 1984: 1
- 1985: 1
- 1990: 1
- 1994: 1
- 2004: 1

## Most-cited predicates
- K042591: Smartmix Pre-Filled Mixing System (2004), cited by 1

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