# ELL: Teeth, Porcelain

- Device class: 2; regulation: 21 CFR 872.3920; FDA's rule: 510(k) required
- FDA decisions: 39
- 510(k) review time 2021–2025: median 342 days (middle half 279–404)
- Recalls: 0 (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)
- 1993: 4
- 1994: 1
- 1996: 2
- 1997: 1
- 2004: 2
- 2006: 1
- 2007: 1
- 2016: 2
- 2022: 1
- 2024: 1

## Most-cited predicates
- K032562: Proceara Copings and Pontic (2004), cited by 5
- K041283: Procera Bridge Zirconia (2004), cited by 3
- K153534: NobelProcera HT ML Full Contour Zirconia Crown (2016), cited by 3
- K910303: Sysnpar Porcelain (1991), cited by 2
- K871808: Duceram-Metal-Ceramic Dental Porcelain System (1987), cited by 2
- K931808: Duceragold, Duceratin (1993), cited by 2
- K060530: SD Ceramic Coping for Quick Abutment, Locking. Model 45301.  RD Ceramic Coping for Quick Abutment, Locking, Model 45302. (2006), cited by 2

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