FDA product code NTK: Light Transmission Caries Detector
NTK is the FDA product code for light transmission caries detector. It is a Class II device, regulated under 21 CFR 872.1745 and reviewed by the Dental panel. FDA has cleared 12 510(k) submissions under NTK, 4 in the last five years, from 10 different applicants. The average 510(k) review took 153 days (median 137); 122 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Light Transmission Caries Detector |
| Device class | Class II |
| Regulation | 21 CFR 872.1745 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NTK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 142 |
| 2019 | 1 | 422 |
| 2020 | 1 | 81 |
| 2022 | 1 | 182 |
| 2024 | 1 | 168 |
| 2025 | 1 | 169 |
| 2026 | 1 | 29 |
Compare with all 510(k) review times · Search every NTK clearance
Top NTK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Align Technology , Ltd. | 2 | 2026-07-02 |
| Kaltenbach & Voigt GmbH | 2 | 2019-11-23 |
| Dentsply Sirona, Inc. | 1 | 2025-08-29 |
| D4D Technologies, LLC | 1 | 2022-04-29 |
| Align Technology, Inc. | 1 | 2020-03-20 |
5 more applicants have NTK clearances. See the full list in Caduvo.
Most recent NTK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261847 | Align Technology , Ltd. | iTero Lumina Pro | 2026-07-02 | 29 |
| K250771 | Dentsply Sirona, Inc. | Primescan 2 | 2025-08-29 | 169 |
| K240573 | Align Technology , Ltd. | iTero Lumina Pro | 2024-08-16 | 168 |
| K213482 | D4D Technologies, LLC | TIA Tip, Cariosity, Transillumination Accessory Tip | 2022-04-29 | 182 |
| K193659 | Align Technology, Inc. | iTero Element 5D | 2020-03-20 | 81 |
Recalls for NTK devices
openFDA lists no recalls for product code NTK.
Frequently asked questions
What is FDA product code NTK?
NTK is the FDA product code for light transmission caries detector. It is a Class II device, regulated under 21 CFR 872.1745 and reviewed by the Dental panel.
What device class is NTK?
Class II, regulation 21 CFR 872.1745. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTK?
Across 12 cleared submissions the average was 153 days from receipt to decision (median 137).
Which companies have the most NTK clearances?
Align Technology , Ltd. (2); Kaltenbach & Voigt GmbH (2); Dentsply Sirona, Inc. (1); D4D Technologies, LLC (1); Align Technology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NTK
- Run a recall and safety report across every NTK manufacturer
- Watch product code NTK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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