# EFD: Amalgamator, Dental, Ac-Powered

- Device class: 1; regulation: 21 CFR 872.3100; FDA's rule: 510(k) exempt
- FDA decisions: 15
- Recalls: 1 (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)
- 1977: 1
- 1978: 1
- 1979: 1
- 1988: 1
- 1989: 2
- 1990: 1
- 1991: 4
- 1992: 3
- 1999: 1

## Most-cited predicates
- K891064: Espe Capmix (1989), cited by 1

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