NBL
- Product code
- NBL
- Device name
- Light-Induced Fluorescence Caries Detector
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.1745
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 24 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252464 | 2026-04-28 | Zumax Medical Co., Ltd. | Surgical Microscope (OMS2360, OMS2380) | |
| K242103 | 2025-04-04 | 3Shape TRIOS A/S | TRIOS Ready Tip | |
| K221275 | 2024-09-04 | AIOBIO Co., Ltd. | Qraycam PRO | |
| K231722 | 2024-05-01 | Smartooth Co., Ltd. | SmarTooth | FDA |
| K223470 | 2023-12-14 | Sopro | C50 |
Official FDA classification page: NBL
Classification and pathway per current FDA publications. Data from openFDA (CC0).