# EBI: Resin, Denture, Relining, Repairing, Rebasing

- Device class: 2; regulation: 21 CFR 872.3760; FDA's rule: 510(k) required
- FDA decisions: 335
- 510(k) review time 2021–2025: median 98 days (middle half 60–153)
- Recalls: 5 (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: 8
- 2018: 5
- 2019: 4
- 2020: 6
- 2021: 4
- 2022: 11
- 2023: 11
- 2024: 9
- 2025: 11
- 2026: 7

## Most-cited predicates
- K053060: TCS Unbreakable (2006), cited by 8
- K011788: Everstick (2001), cited by 8
- K191497: NextDent Denture 3D+ (2019), cited by 6
- K162044: Dentca Denture Base II (2017), cited by 6
- K162572: NextDent Denture, E-Denture (2017), cited by 5
- K913040: Ribbond (TM) (1991), cited by 5
- K892452: Palaseal (R) (1989), cited by 4
- K063626: Duraflex (2007), cited by 4
- K151142: Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid (2015), cited by 4
- K913655: Probase Hot and Probase Cold (1991), cited by 4

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