# EBD: Coating, Filling Material, Resin

- Device class: 2; regulation: 21 CFR 872.3310; FDA's rule: 510(k) required
- FDA decisions: 52
- 510(k) review time 2021–2025: median 152 days (middle half 128–187)
- 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)
- 2009: 1
- 2013: 1
- 2014: 1
- 2017: 1
- 2018: 1
- 2021: 1
- 2023: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K133836: Optiglaze Color (2014), cited by 4
- K030585: Sculpting Resin (2003), cited by 3
- K043168: Biscover LV (2005), cited by 3
- K052462: G-COAT (2005), cited by 2
- K030354: Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover Viscosity Modifier (2003), cited by 2
- K123761: Vita Enamic Stains (2013), cited by 2
- K992067: Belleglaze (1999), cited by 1
- K211854: VITA Akzent LC (2021), cited by 1
- K021503: Uninhibited (2002), cited by 1
- K040599: Parkell Resin Glaze (2004), cited by 1

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