# EJH: Alloy, Metal, Base

- Device class: 2; regulation: 21 CFR 872.3710; FDA's rule: 510(k) exempt
- FDA decisions: 153
- 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)
- 1996: 2
- 1997: 9
- 1998: 3
- 1999: 6
- 2000: 11
- 2001: 6
- 2002: 10
- 2003: 9
- 2004: 2
- 2013: 1

## Most-cited predicates
- K032136: Wirobond C (2003), cited by 1
- K001798: DC Titan (2000), cited by 1
- K003039: Gold Core II (2000), cited by 1
- K880875: Vitallium Equipoise Alloy (1988), cited by 1
- K901552: (CP) Titanium and TI6AI-4V Alloy for Fixed Prosthe (1991), cited by 1

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