# EJJ: Alloy, Amalgam

- Device class: 2; regulation: 21 CFR 872.3070; FDA's rule: 510(k) required
- FDA decisions: 74
- 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)
- 1995: 4
- 1996: 2
- 1997: 4
- 1998: 4
- 1999: 1
- 2000: 3
- 2001: 1
- 2002: 1
- 2003: 3
- 2005: 2

## Most-cited predicates
- K902249: Luxalloy 50 (Powder, Tablets, Predosed Capsules) (1990), cited by 1
- K801639: Permite Dental Amalgam Alloy (1980), cited by 1
- K940675: Sybraloy (1994), cited by 1
- K820181: Sybron/Kerr Contour (1982), cited by 1
- K801690: Valiant (1980), cited by 1

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