FDA product code NBL: Light-Induced Fluorescence Caries Detector
NBL is the FDA product code for light-induced fluorescence caries detector. It is a Class II device, regulated under 21 CFR 872.1745 and reviewed by the Dental panel. FDA has cleared 23 510(k) submissions under NBL, 6 in the last five years, from 18 different applicants. The average 510(k) review took 278 days (median 265); 372 days on average over the last three years. 1 De Novo request was granted under it.
Classification
| Field | Value |
|---|---|
| Device name | Light-Induced Fluorescence Caries Detector |
| Device class | Class II |
| Regulation | 21 CFR 872.1745 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
510(k) clearances per year for NBL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 175 |
| 2018 | 1 | 394 |
| 2020 | 1 | 566 |
| 2022 | 1 | 137 |
| 2023 | 1 | 392 |
| 2024 | 2 | 590 |
| 2025 | 1 | 260 |
| 2026 | 1 | 265 |
Compare with all 510(k) review times · Search every NBL clearance
Top NBL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sopro | 3 | 2023-12-14 |
| 3Shape TRIOS A/S | 2 | 2025-04-04 |
| Cariescan , Ltd. | 2 | 2011-05-17 |
| Neks Technologies, Inc. | 2 | 2007-03-30 |
| Zumax Medical Co., Ltd. | 1 | 2026-04-28 |
13 more applicants have NBL clearances. See the full list in Caduvo.
Most recent NBL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252464 | Zumax Medical Co., Ltd. | Surgical Microscope (OMS2360, OMS2380) | 2026-04-28 | 265 |
| K242103 | 3Shape TRIOS A/S | TRIOS Ready Tip | 2025-04-04 | 260 |
| K221275 | AIOBIO Co., Ltd. | Qraycam PRO | 2024-09-04 | 856 |
| K231722 | Smartooth Co., Ltd. | SmarTooth | 2024-05-01 | 323 |
| K223470 | Sopro | C50 | 2023-12-14 | 392 |
Recalls for NBL devices
openFDA lists no recalls for product code NBL.
Frequently asked questions
What is FDA product code NBL?
NBL is the FDA product code for light-induced fluorescence caries detector. It is a Class II device, regulated under 21 CFR 872.1745 and reviewed by the Dental panel.
What device class is NBL?
Class II, regulation 21 CFR 872.1745. Typical premarket route: 510(k).
How long does a 510(k) take for product code NBL?
Across 23 cleared submissions the average was 278 days from receipt to decision (median 265).
Which companies have the most NBL clearances?
Sopro (3); 3Shape TRIOS A/S (2); Cariescan , Ltd. (2); Neks Technologies, Inc. (2); Zumax Medical Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NBL
- Run a recall and safety report across every NBL manufacturer
- Watch product code NBL 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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