# LBH: Varnish, Cavity

- Device class: 2; regulation: 21 CFR 872.3260; FDA's rule: 510(k) required
- FDA decisions: 139
- 510(k) review time 2021–2025: median 216 days (middle half 113–241)
- Recalls: 6 (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)
- 2014: 6
- 2015: 2
- 2016: 2
- 2019: 2
- 2020: 5
- 2022: 1
- 2023: 3
- 2024: 3
- 2025: 4
- 2026: 5

## Most-cited predicates
- K945794: Duraphat (1995), cited by 8
- K092141: Vanish Varnish, 5% Sodium Fluoride White Varnish (2010), cited by 7
- K961893: Duraflor (1996), cited by 5
- K132109: Enamelast (2013), cited by 4
- K925375: Consepsis Scrub (1993), cited by 4
- K982915: Sci-Pharm DFV Varnish (1999), cited by 4
- K061438: Ultraez Desensitizing Gel (2007), cited by 4
- K050486: Protect Tooth Desensitizer (2005), cited by 3
- K082198: Durashield Plus (2008), cited by 3
- K120109: Super Seal Tooth Desensitizer (2012), cited by 3

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