Data / Medical devices / Light-Induced Fluorescence Caries Detector
Light-Induced Fluorescence Caries Detector (NBL): 15 FDA-registered makers in 9 countries
15 establishments in 9 countries are registered with the FDA to make Light-Induced Fluorescence Caries Detector (product code NBL, Class 2, 21 CFR 872.1745). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on April 28, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NBL
- Device class
- 2
- Regulation
- 872.1745
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| Germany | 5 |
| South Korea | 3 |
| France | 1 |
| Denmark | 1 |
| China | 1 |
| United States | 1 |
| Poland | 1 |
| United Kingdom | 1 |
| Switzerland | 1 |
Makers of Light-Induced Fluorescence 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 |
|---|---|---|---|---|---|---|---|---|
| Sopro | LA CIOTAT CEDEX Bouches-du-Rhone, France | Manufacturer | 3 | December 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| 3shape Trios A/S | copenhagen Hovedstaden, Denmark | Manufacturer | 2 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Kavo Dental GMBH | WARTHAUSEN Baden-Wurttemberg, Germany | Manufacturer | 2 | August 2, 2005 | 0 | 0 | 0 | api.fda.gov |
| Aiobio Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | September 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | May 3, 2018 | 0 | 0 | 0 | api.fda.gov |
| Durr Dental Se | Bietigheim-Bissingen Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 1 | January 27, 2016 | 0 | 0 | 0 | api.fda.gov |
| Durr Optronik GmbH & Co. KG | Gechingen Baden-Wurttemberg, Germany | Manufacturer | 1 | January 27, 2016 | 0 | 0 | 0 | api.fda.gov |
| Good Doctors Co., Ltd. | Incheon Seoul, South Korea | Manufacturer | 1 | July 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Smartooth Co., Ltd. | Anyang-si Gyeonggi, South Korea | Manufacturer | 1 | May 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| 3Shape Inc. | Morrisville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| 3Shape Poland Sp. zo.o | Szczecin Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JENOPTIK Optical Systems GmbH | Berlin, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marturion Electronics Ltd | Lisburn Northern Ireland, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zetta25 AG | Zurich, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 28, 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.