# EBF: Material, Tooth Shade, Resin

- Device class: 2; regulation: 21 CFR 872.3690; FDA's rule: 510(k) required
- FDA decisions: 936
- 510(k) review time 2021–2025: median 92 days (middle half 53–179)
- Recalls: 66 (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: 15
- 2018: 15
- 2019: 17
- 2020: 15
- 2021: 13
- 2022: 17
- 2023: 9
- 2024: 18
- 2025: 15
- 2026: 16

## Most-cited predicates
- K042819: Tetric Evoceram (2004), cited by 14
- K083610: Filtek Supreme Ultra Universal Restorative (2008), cited by 11
- K012740: Clearfil AP-X (2001), cited by 11
- K100235: Filtek Supreme Ultra Flowable Restorative (2010), cited by 9
- K993783: Tetric Flow (1999), cited by 7
- K091388: GCUC-505 (2009), cited by 6
- K012307: Luxacore/Luxacore Dual (2001), cited by 6
- K120453: Filtek Bulk Fill Flowable Restorative (2012), cited by 6
- K133824: Cerasmart (2014), cited by 5
- K110131: Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative (2011), cited by 5

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