# LFC: Device, Caries Detection

- Device class: 2; regulation: 21 CFR 872.1740; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 325 days (middle half 295–355)
- 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)
- 1997: 2
- 1998: 1
- 2000: 1
- 2001: 1
- 2003: 1
- 2006: 1
- 2011: 1
- 2020: 1
- 2021: 1
- 2023: 1

## Most-cited predicates
- K200601: LumiCare Caries Diagnostic Rinse (2021), cited by 1
- K913405: Kar-D-Tek (1991), cited by 1
- K951813: Caries Detector (1995), cited by 1
- K982105: Oral Potential Meter (Opm) (1998), cited by 1
- K012733: Caries Detector (2001), cited by 1
- K955445: Caries Finder (1996), cited by 1
- K964430: Pulpdent Snoop (1997), cited by 1

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