# ELW: Material, Impression

- Device class: 2; regulation: 21 CFR 872.3660; FDA's rule: 510(k) required
- FDA decisions: 404
- 510(k) review time 2021–2025: median 76 days (middle half 60–120)
- Recalls: 13 (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: 5
- 2019: 2
- 2020: 4
- 2021: 3
- 2022: 7
- 2023: 2
- 2024: 3
- 2025: 2
- 2026: 3

## Most-cited predicates
- K170736: HySil Impression Materials (2017), cited by 6
- K974231: Position Penta, Position Penta Quick (1998), cited by 5
- K000629: Flextime (2000), cited by 5
- K082560: Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact (2008), cited by 5
- K040053: Precision VPS Impression Material (2004), cited by 4
- K943574: Capture Impression Material (1994), cited by 4
- K021413: Aquasil Ultra Rigid Smart Wetting Impression Material (2002), cited by 4
- K954281: Panasil Impression Material (1996), cited by 4
- K021416: Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material (2002), cited by 4
- K882690: Imprint Vinyl Polysiloxane Impression Material (1988), cited by 4

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