NTK — Light Transmission Caries Detector Class II
FDA product code NTK covers "Light Transmission Caries Detector", a Class II medical device regulated under 21 CFR 872.1745. Submissions are reviewed by the Dental panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NTK
- Device Class
- Class II
- Regulation Number
- 872.1745
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261847 | align technology | iTero Lumina Pro | July 2, 2026 |
| K250771 | dentsply sirona | Primescan 2 | August 29, 2025 |
| K240573 | align technology | iTero Lumina Pro | August 16, 2024 |
| K213482 | d4d technologies | TIA Tip, Cariosity, Transillumination Accessory Tip | April 29, 2022 |
| K193659 | align technology | iTero Element 5D | March 20, 2020 |
| K182712 | kaltenbach and voigt | DEXIS CariVu 3-in-1 by KaVo | November 23, 2019 |
| K172007 | duerr dental | CamX Triton HD Proxi Head | November 22, 2017 |
| K123402 | kaltenbach and voigt | DIAGNOCAM | September 24, 2013 |
| K071429 | kerr corporation | TI2200 TRANSILLUMINATION CABLE | September 10, 2007 |
| K062961 | addent | MICROLUX TRANSILLUMINATOR | February 8, 2007 |
| K060080 | kavo dental corporation | DIAGNODENT 2190 WITH PERIODONTAL PROBE | February 8, 2006 |
| K043068 | electro-optical sciences | DIFOTI USB 2.0 SYSTEM | December 29, 2004 |