NTK
12 FDA 510(k) clearances · Product code
142 daysmedian time to decision
323 days90th percentile
12clearances measured
FDA profile
- Official device name
- Light Transmission Caries Detector
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.1745
- Medical specialty
- Dental
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| iTero Lumina™ Pro (K261847) | Align Technology , Ltd. | 2026-07-02 |
| Primescan 2 (K250771) | Dentsply Sirona, Inc. | 2025-08-29 |
| iTero Lumina™ Pro (K240573) | Align Technology , Ltd. | 2024-08-16 |
| TIA Tip, Cariosity, Transillumination Accessory Tip (K213482) | D4D Technologies, LLC | 2022-04-29 |
| iTero Element 5D (K193659) | Align Technology, Inc. | 2020-03-20 |
| DEXIS CariVu 3-in-1 by KaVo (K182712) | Kaltenbach & Voigt GmbH | 2019-11-23 |
| CamX Triton HD Proxi Head (K172007) | Duerr Dental AG | 2017-11-22 |
| DIAGNOCAM (K123402) | Kaltenbach & Voigt GmbH | 2013-09-24 |
| TI2200 TRANSILLUMINATION CABLE (K071429) | Kerr Corporation | 2007-09-10 |
| MICROLUX TRANSILLUMINATOR (K062961) | Addent, Inc. | 2007-02-08 |
| DIAGNODENT 2190 WITH PERIODONTAL PROBE (K060080) | Kavo Dental Corporation | 2006-02-08 |
| DIFOTI USB 2.0 SYSTEM (K043068) | Electro-Optical Sciences, Inc. | 2004-12-29 |
Track NTK automatically
Every clearance here is in the API, with alerts when new ones post.