# KLE: Agent, Tooth Bonding, Resin

- Device class: 2; regulation: 21 CFR 872.3200; FDA's rule: 510(k) required
- FDA decisions: 421
- 510(k) review time 2021–2025: median 96 days (middle half 61–150)
- Recalls: 16 (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: 4
- 2018: 8
- 2019: 6
- 2020: 6
- 2021: 4
- 2022: 8
- 2023: 6
- 2024: 7
- 2025: 3
- 2026: 7

## Most-cited predicates
- K110302: Adhesive Exl-759 (2011), cited by 15
- K042913: Clearfil Tri-S Bond (2004), cited by 11
- K012442: Modification to Clearfil SE Bond (2001), cited by 10
- K962785: 3M Dent System (1996), cited by 8
- K982394: Prime & Bond NT Dual Cure Universal Dental Adhesive System (1998), cited by 8
- K910860: All-Bond 2 (1991), cited by 7
- K943165: Clearfil Photo Bond (1994), cited by 6
- K012432: Modification to Clearfil Photo Bond (2001), cited by 5
- K990040: Clearfil SE Bond (1999), cited by 5
- K942493: Scotchbond Multi-Purpose Plus Dental Adhesive System (1994), cited by 4

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