# KIF: Resin, Root Canal Filling

- Device class: 2; regulation: 21 CFR 872.3820; FDA's rule: 510(k) required
- FDA decisions: 148
- 510(k) review time 2021–2025: median 90 days (middle half 59–136)
- Recalls: 1 (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)
- 2017: 3
- 2018: 5
- 2019: 7
- 2020: 3
- 2021: 12
- 2022: 3
- 2023: 7
- 2024: 8
- 2025: 7
- 2026: 7

## Most-cited predicates
- K080917: Iroot SP (2008), cited by 12
- K960548: AH Plus Root Canal Sealer (1996), cited by 11
- K011009: White Mta Material (2001), cited by 6
- K092715: Iroot BP Plus (2009), cited by 5
- K042769: Adseal Root Canal Sealer (2004), cited by 5
- K082943: Iroot BP, Model Irbp 4609 (2009), cited by 5
- K170175: Endoseal Mta (2018), cited by 5
- K973667: Vitapex Pre-Loaded Dental Syringe (1997), cited by 4
- K032603: Metapex Calcium Hydroxide with Lodoform Temporary Root Canal Filling (2003), cited by 4
- K063422: Bioaggregate (2006), cited by 4

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