# PHR: Diammine Silver Fluoride Dental Hypersensitivity Varnish

- Device class: 2; regulation: 21 CFR 872.3260; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 224 days (middle half 107–323)
- 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)
- 2014: 1
- 2018: 1
- 2023: 2
- 2024: 2
- 2025: 2

## Most-cited predicates
- K102973: Silver Dental Arrest (2014), cited by 6

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