NTK

Light Transmission Caries Detector

Product code
NTK
Device name
Light Transmission Caries Detector
Device class
Class 2
21 CFR
21 CFR 872.1745
Medical specialty
Dental
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
3
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
12 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-07-02.

NumberDecision dateApplicantDevice nameSummary
K2618472026-07-02Align Technology , Ltd.iTero Lumina™ ProPDF
K2507712025-08-29Dentsply Sirona, Inc.Primescan 2PDF
K2405732024-08-16Align Technology , Ltd.iTero Lumina™ ProFDA

2 summaries are archived here for direct download.

Official FDA classification page: NTK
Classification and pathway per current FDA publications. Data from openFDA (CC0).