# EMA: Cement, Dental

- Device class: 2; regulation: 21 CFR 872.3275; FDA's rule: 510(k) required
- FDA decisions: 509
- 510(k) review time 2021–2025: median 112 days (middle half 64–226)
- Recalls: 11 (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: 3
- 2018: 3
- 2019: 7
- 2020: 8
- 2021: 4
- 2022: 7
- 2023: 2
- 2024: 3
- 2025: 10
- 2026: 7

## Most-cited predicates
- K032455: Panavia F 2.0 (2003), cited by 14
- K020256: Unicem (2002), cited by 8
- K960464: C & B Metabond (Modification) (1996), cited by 7
- K960954: Ketac-Molar Aplicap (1996), cited by 6
- K933030: Panavia 21 (1994), cited by 6
- K111185: Relyx Luting Plus Automix (2011), cited by 5
- K100756: MALTA (2010), cited by 5
- K053040: Paracem Universal DC (2005), cited by 4
- K933139: 3M Vitremer Luting Cement (1994), cited by 4
- K041474: Maxcem (2004), cited by 4

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