# DYH: Adhesive, Bracket And Tooth Conditioner, Resin

- Device class: 2; regulation: 21 CFR 872.3750; FDA's rule: 510(k) required
- FDA decisions: 195
- 510(k) review time 2021–2025: median 82 days (middle half 1–184)
- 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)
- 2016: 2
- 2018: 1
- 2019: 1
- 2020: 3
- 2021: 1
- 2022: 1
- 2023: 2
- 2024: 1
- 2025: 1
- 2026: 3

## Most-cited predicates
- K880393: Transbond Light Cured Orthodontic Adhesive (1988), cited by 6
- K083051: Flowtain & Flowtain LV (2009), cited by 5
- K020394: Apc Plus Adhesive (2002), cited by 4
- K073697: Transbond Supreme Adhesive (2008), cited by 3
- K941015: Ormco System 1+ (TM) (1994), cited by 2
- K880792: Plastic Primer (1988), cited by 2
- K231817: AlignerFlow LC (2023), cited by 2
- K061252: Pre-Cemented Orthodontic Bracket System (2007), cited by 2
- K001048: Light Bond (Quick Cure) (2000), cited by 2
- K033703: Ideal 1 Orthodontic Bracket Adhesive (2004), cited by 2

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