# MCF: Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile

- Device class: 1; regulation: 21 CFR 872.6855; FDA's rule: 510(k) exempt
- FDA decisions: 5
- 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)
- 1990: 2
- 2001: 1
- 2002: 1
- 2003: 1

## Most-cited predicates
- K003517: Otres Toothbrush Sanitizer Model TB100W (2001), cited by 1

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