# EKM: Gutta-Percha

- Device class: 1; regulation: 21 CFR 872.3850; FDA's rule: 510(k) exempt
- FDA decisions: 23
- 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)
- 1990: 2
- 1991: 1
- 1992: 1
- 1993: 2
- 1997: 2
- 2003: 1
- 2005: 1
- 2006: 1
- 2007: 1
- 2008: 1

## Most-cited predicates
- K832654: Heated Gutta Percha Delivery System (1983), cited by 1
- K910224: Thermaprep (1991), cited by 1
- K896663: Endo-Prep (1990), cited by 1

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