# NTK: Light Transmission Caries Detector

- Device class: 2; regulation: 21 CFR 872.1745; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 169 days (middle half 169–176)
- 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)
- 2006: 1
- 2007: 2
- 2013: 1
- 2017: 1
- 2019: 1
- 2020: 1
- 2022: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K172007: CamX Triton HD Proxi Head (2017), cited by 2
- K071429: TI2200 Transillumination Cable (2007), cited by 2
- K123402: Diagnocam (2013), cited by 2
- K043068: Difoti Usb 2.0 System (2004), cited by 2
- K193659: iTero Element 5D (2020), cited by 1
- K060080: Diagnodent 2190 with Periodontal Probe (2006), cited by 1
- K062961: Microlux Transilluminator (2007), cited by 1
- K240573: iTero Lumina™ Pro (2024), cited by 1
- K182712: DEXIS CariVu 3-in-1 by KaVo (2019), cited by 1

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