# NBL: Light-Induced Fluorescence Caries Detector

- Device class: 2; regulation: 21 CFR 872.1745; FDA's rule: 510(k) required
- FDA decisions: 24
- 510(k) review time 2021–2025: median 323 days (middle half 260–392)
- 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)
- 2013: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2020: 1
- 2022: 1
- 2023: 1
- 2024: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- DEN990002: Kavo Diagnodent (2000), cited by 8
- K040063: Inspektor Pro (2004), cited by 5
- K051909: Diagnodent (2005), cited by 3
- K150672: VistaCam iX Proof (2016), cited by 3
- K042394: Diagnodent Perio Tip (Accessory) (2005), cited by 2
- K092583: Soprolife (2010), cited by 2
- K121685: Soprocare (2013), cited by 1
- K090598: Cariescan Pro (2009), cited by 1
- K090169: Spectra Fluorescence Caries Detection Device (2009), cited by 1
- K171007: Fluorescence Mode (2018), cited by 1

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