# EJB: Handle, Instrument, Dental

- Device class: 1; regulation: 21 CFR 872.4565; FDA's rule: 510(k) exempt
- FDA decisions: 8
- 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)
- 1983: 2
- 1987: 1
- 1992: 1
- 1993: 1
- 1998: 1
- 2003: 1
- 2014: 1

## Most-cited predicates
- K023367: Detectar, Model N123-MI (2003), cited by 3

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