# EBG: Crown And Bridge, Temporary, Resin

- Device class: 2; regulation: 21 CFR 872.3770; FDA's rule: 510(k) required
- FDA decisions: 189
- 510(k) review time 2021–2025: median 144 days (middle half 62–187)
- Recalls: 4 (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: 2
- 2018: 4
- 2019: 6
- 2020: 14
- 2021: 3
- 2022: 3
- 2023: 2
- 2024: 5
- 2025: 4
- 2026: 2

## Most-cited predicates
- K150432: Idodentine Disc, Idodentine Block (2015), cited by 6
- K101710: Luxatemp Ultra /Star (2010), cited by 6
- K102776: Extra-Oral, Additive Computer Aided Manufacture and Curing System (2011), cited by 5
- K071548: Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored (2007), cited by 5
- K093708: Telio Cad (2010), cited by 5
- K924830: Luxatemp Automix (1994), cited by 4
- K033022: Protemp 3 Garant (2003), cited by 4
- K002364: Protemp H (2000), cited by 4
- K073296: TEMPXN28 (2008), cited by 4
- K955331: Belleglashp (1996), cited by 3

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