# NTO: Rinse, Oral, Antibacterial (By Physical Means)

- Device class: 2; regulation: 21 CFR 872.5580; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 1 (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)
- 2005: 1
- 2006: 1

## Most-cited predicates
- DEN050001: Decapinol Oral Rinse (2005), cited by 1

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