Data / Medical devices / Light Transmission Caries Detector
Light Transmission Caries Detector (NTK): 14 FDA-registered makers in 7 countries
14 establishments in 7 countries are registered with the FDA to make Light Transmission Caries Detector (product code NTK, Class 2, 21 CFR 872.1745). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on July 2, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NTK
- Device class
- 2
- Regulation
- 872.1745
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| Germany | 5 |
| Mexico | 2 |
| United States | 2 |
| Switzerland | 2 |
| Israel | 1 |
| Finland | 1 |
| Thailand | 1 |
Makers of Light Transmission Caries Detector
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Align Technology, Ltd. | Petach Tikva Central, Israel | Manufacturer | 3 | July 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Aligntech de Mexico S, de R. L. de C. V. | Cd. Juarez Chihuahua, Mexico | Manufacturer | 3 | July 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Aligntech de Mexico S, de R. L. de C. V. | Cd. Juarez Chihuahua, Mexico | Manufacturer | 3 | July 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Kavo Dental GMBH | WARTHAUSEN Baden-Wurttemberg, Germany | Manufacturer | 3 | November 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Addent, Inc. | Danbury, CT, United States | Manufacturer | 1 | February 8, 2007 | 0 | 0 | 0 | api.fda.gov |
| Durr Dental Se | Bietigheim-Bissingen Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 1 | November 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Durr Optronik GmbH & Co. KG | Gechingen Baden-Wurttemberg, Germany | Manufacturer | 1 | November 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Planmeca Oy | Helsinki Uusimaa, Finland | Manufacturer | 1 | April 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Manufacturer | 1 | August 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zetta25 AG | Zurich, Switzerland | Manufacturer | 1 | August 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | Milford, DE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabrinet Co., Ltd. | Sriracha Chon Buri, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-Dent Innovations For Dentistry SA | Nyon Vaud, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JENOPTIK Optical Systems GmbH | Berlin, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.