# EJT: Alloy, Gold-Based Noble Metal

- Device class: 2; regulation: 21 CFR 872.3060; FDA's rule: 510(k) exempt
- FDA decisions: 627
- 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: 32
- 1997: 34
- 1998: 9
- 1999: 9
- 2000: 22
- 2001: 25
- 2002: 36
- 2003: 31
- 2004: 6
- 2005: 1

## Most-cited predicates
- K003603: Bio Herador SG, Bio Header GG, Herador S, Bio Herador N, Herabond, Heraloy G, Albabond, Bio Maingold SG, Maingold SG, HE (2001), cited by 3
- K993508: V-Supra Plus, Alloy NO. 5025 (1999), cited by 3
- K951787: Degubond 4 (1995), cited by 2
- K911541: Pontor 4 CF (1991), cited by 2
- K905387: Degudent GS (1991), cited by 2
- K942505: Argesol-WSF Pre-Solder for High Gold Dental Procelain Alloys (1994), cited by 2
- K943779: Argesol #720 (1994), cited by 2
- K951780: Stabilor NF IV (1995), cited by 2
- K944572: V-Delta N (V-Delta Loy), Aurofluid 2PF (1994), cited by 2
- K012826: Bioporta G, Model 2052 (2001), cited by 2

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