# EKJ: Burnisher, Operative

- Device class: 1; regulation: 21 CFR 872.4565; FDA's rule: 510(k) exempt
- FDA decisions: 72
- 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)
- 1987: 1
- 1988: 12
- 1989: 18
- 1990: 14
- 1991: 6
- 1992: 2
- 1993: 3
- 1994: 11
- 1995: 2
- 1996: 2

## Most-cited predicates
- K943584: Presterilized Endodontic Files (1994), cited by 2
- K882821: Vitrabond Light Cure Glass Ionomer Liner (1988), cited by 2
- K951607: Sureflex Files (1995), cited by 1
- K880849: Examix Dispenser (1988), cited by 1

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