NTK
- 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)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261847 | 2026-07-02 | Align Technology , Ltd. | iTero Lumina Pro | |
| K250771 | 2025-08-29 | Dentsply Sirona, Inc. | Primescan 2 | |
| K240573 | 2024-08-16 | Align Technology , Ltd. | iTero Lumina Pro | FDA |
Official FDA classification page: NTK
Classification and pathway per current FDA publications. Data from openFDA (CC0).