# EBC: Sealant, Pit And Fissure, And Conditioner

- Device class: 2; regulation: 21 CFR 872.3765; FDA's rule: 510(k) required
- FDA decisions: 131
- 510(k) review time 2021–2025: median 154 days (middle half 78–226)
- 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)
- 2013: 1
- 2014: 1
- 2015: 1
- 2016: 1
- 2017: 2
- 2018: 1
- 2019: 2
- 2023: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K992326: 3M Clinpro Sealant (1999), cited by 7
- K993846: Ultraseal XT Plus (2000), cited by 3
- K020287: Dentition Integrating Material (2002), cited by 3
- K951296: Delton F Pit & Fissure Sealant (1995), cited by 3
- K052281: Embrace Wetbond Clear Sealant (2006), cited by 3
- K062344: Grandio Seal (2006), cited by 2
- K982564: Delton FS Direct Delivery System (1998), cited by 2
- K890464: Zenith 40% Phosphoric Acid Gel (1989), cited by 2
- K932078: Helioseal F (1993), cited by 2
- K963921: Pulpdent Seal-Rite Udma (1996), cited by 2

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