# EBZ: Activator, Ultraviolet, For Polymerization

- Device class: 2; regulation: 21 CFR 872.6070; FDA's rule: 510(k) required
- FDA decisions: 214
- 510(k) review time 2021–2025: median 105 days (middle half 25–246)
- Recalls: 3 (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: 2
- 2019: 5
- 2020: 5
- 2021: 1
- 2022: 5
- 2023: 3
- 2024: 1
- 2025: 4
- 2026: 1

## Most-cited predicates
- K110582: Valo Cordless (2011), cited by 6
- K032465: Mini L.E.D., Model: Mini L.E.D., Model Smartlite Mini (2003), cited by 5
- K041372: Smartlite PS Pen-Style Led Curing Light (2004), cited by 5
- K200809: D-LUX+ (2020), cited by 4
- K170529: Delight, Delight ortho, B&Lite S (2017), cited by 3
- K040551: Coltolux Led Curing Light (2004), cited by 3
- K020091: Optilux 501 (2002), cited by 3
- K011154: Elipar Freelight (2001), cited by 3
- K021797: L.E.Demetron (2002), cited by 2
- K961735: ACTA (1996), cited by 2

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