# EJK: Liner, Cavity, Calcium Hydroxide

- Device class: 2; regulation: 21 CFR 872.3250; FDA's rule: 510(k) required
- FDA decisions: 78
- 510(k) review time 2021–2025: median 227 days (middle half 117–254)
- 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)
- 2013: 1
- 2014: 1
- 2015: 3
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2026: 2

## Most-cited predicates
- K983477: Super Seal (1998), cited by 5
- K063237: Theracal LC (2006), cited by 4
- K201799: CleaniCal (2021), cited by 2
- K944945: Pulpdent Calcium Hydroxide Preparations (1994), cited by 2
- K953079: Limelight (1995), cited by 2
- K970113: Ultra-Blend Plus (1997), cited by 2
- K033521: Bisblock (2004), cited by 2
- K060365: Apexcal (2006), cited by 2
- K122421: Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer Liquid (2012), cited by 1
- K841910: Kerr Sealapex Root Canal Sealer (1984), cited by 1

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