# EKS: File, Pulp Canal, Endodontic

- Device class: 1; regulation: 21 CFR 872.4565; FDA's rule: 510(k) exempt
- FDA decisions: 31
- Recalls: 2 (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)
- 1989: 3
- 1990: 2
- 1991: 3
- 1993: 2
- 1994: 1
- 1995: 1
- 1996: 1
- 1997: 2
- 2001: 1
- 2006: 1

## Most-cited predicates
- K962031: Quantec Series 2000 Endodontic Files (1996), cited by 3
- K933582: Profile Series 29 Files (1993), cited by 2
- K062856: TF Rotary Nickel Titanium File (2006), cited by 1
- K004031: NT Swift; TI\Tec; Gates Glidden Drills; Dental Power Endodontic Hand Files (2001), cited by 1

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