# EJS: Alloy, Other Noble Metal

- Device class: 2; regulation: 21 CFR 872.3060; FDA's rule: 510(k) exempt
- FDA decisions: 194
- 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)
- 1993: 8
- 1994: 3
- 1996: 7
- 1997: 7
- 1998: 7
- 1999: 8
- 2000: 3
- 2001: 4
- 2002: 9
- 2004: 2

## Most-cited predicates
- K913704: Argebond 80 (1991), cited by 1
- K993475: Aurofluid M, Alloy NO. 5315 (1999), cited by 1
- K911675: Pagalin 2 (1991), cited by 1
- K911669: Cerapall 6 (1991), cited by 1
- K920887: GDC-3338, Dental Solder Alloy (1992), cited by 1
- K921419: Deva Plus (1992), cited by 1
- K922958: KB58-KF (1993), cited by 1

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