# ELS: Splint, Endodontic Stabilizing

- Device class: 2; regulation: 21 CFR 872.3890; FDA's rule: 510(k) exempt
- FDA decisions: 6
- 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)
- 1980: 1
- 1981: 1
- 1984: 1
- 1994: 1
- 1996: 1
- 1997: 1

## Most-cited predicates
- K972985: Splint IT (1997), cited by 2
- K834363: Endix Radicular Bioceramic Pin (1984), cited by 1
- K961704: Mti-MP Transitional Implants and Modular Prosthetic System (1996), cited by 1

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