# KJJ: Cleanser, Root Canal

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 41
- 510(k) review time 2021–2025: median 129 days (middle half 97–223)
- Recalls: 7 (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: 2
- 2014: 2
- 2015: 2
- 2016: 2
- 2017: 1
- 2018: 1
- 2020: 3
- 2021: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K053167: Biopure Mtad Root Canal Cleanser (2005), cited by 9
- K082470: Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension Marketed as Chlor-Xtra (2009), cited by 5
- K061689: Aquatine EC Endodontic Cleanser (2006), cited by 5
- K103244: Qmix 2IN1 Endodontic Irrigating Solution (2011), cited by 4
- K962743: Pulpdent Sodium Hypochlorite Solution (1996), cited by 3
- K032361: Endopure Root Canal Cleanser (2004), cited by 2
- K063703: Citric Acid 20% Solution, Model 329 (2006), cited by 2
- K950365: Moyco-Edta (1995), cited by 2
- K992919: Oxy-Glide Root Canal Cleanser & Lub. (1999), cited by 1
- K193409: Vista Rinse, Vista Rinse Plus (2020), cited by 1

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