NBLClass II
Light-Induced Fluorescence Caries Detector
21 CFR 872.1745 / Dental
NBL is the FDA product code for Light-Induced Fluorescence Caries Detector, a class II device type, regulated under 21 CFR 872.1745. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NBL
- Device name
- Light-Induced Fluorescence Caries Detector
- Regulation
- 21 CFR 872.1745
- Device class
- Class II
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 24
- Ingested recalls
- 0
Clearances, product code NBL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2004 | 1 |
| 2005 | 3 |
| 2007 | 1 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code NBL| Applicant | Clearances |
|---|---|
| Kavo America | 3 |
| 3SHAPE Trios a/S | 2 |
| Cariescan, Ltd. | 2 |
| Neks Technologies, Inc. | 2 |
| Sopro | 2 |
| Aiobio Co., Ltd. | 1 |
| Air Techniques, Inc. | 1 |
| Eastman Kodak Company | 1 |
| Carl Zeiss Suzhou Co., Ltd. | 1 |
| Durr Dental AG | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.