NBL
24 FDA 510(k) clearances · Product code
265 daysmedian time to decision
458 days90th percentile
24clearances measured
FDA profile
- Official device name
- Light-Induced Fluorescence Caries Detector
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.1745
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Surgical Microscope (OMS2360, OMS2380) (K252464) | Zumax Medical Co., Ltd. | 2026-04-28 |
| TRIOS Ready Tip (K242103) | 3Shape TRIOS A/S | 2025-04-04 |
| Qraycam PRO (K221275) | AIOBIO Co., Ltd. | 2024-09-04 |
| SmarTooth (K231722) | Smartooth Co., Ltd. | 2024-05-01 |
| C50 (K223470) | Sopro | 2023-12-14 |
| L1P-1F (TRIOS 5) (K221249) | 3Shape TRIOS A/S | 2022-09-16 |
| IC-WHCD100 (Inspire) (K183471) | Good Doctors Co., Ltd. | 2020-07-02 |
| Fluorescence Mode (K171007) | Carl Zeiss Suzhou Co., Ltd. | 2018-05-03 |
| Electronic Caries Detector (K170822) | Ortek Therapeutics, Inc. | 2017-09-11 |
| VistaCam iX Proof (K150672) | Durr Dental AG | 2016-01-27 |
| SOPROCARE (K121685) | Sopro | 2013-03-12 |
| THE CANARY SYSTEM (K112139) | Quantum Dental Technologies, Inc. | 2012-10-26 |
| CS 1600 INTRAORAL CAMERA (K111423) | Carestream Health, Inc. | 2012-03-02 |
| REMOTE VIEW SOFTWARE (K111321) | Cariescan , Ltd. | 2011-05-17 |
| FUORECAM (K093705) | Therapeutic Technologies, Inc. | 2010-04-23 |
| SOPROLIFE (K092583) | Sopro | 2010-01-13 |
| CARIESCAN PRO (K090598) | Cariescan , Ltd. | 2009-12-15 |
| SPECTRA FLUORESCENCE CARIES DETECTION DEVICE (K090169) | Air Techniques, Inc. | 2009-08-18 |
| D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 (K063321) | Neks Technologies, Inc. | 2007-03-30 |
| DIAGNODENT (K051909) | Kavo America | 2005-10-21 |
| DIAGNODENT PERIO TIP (ACCESSORY) (K042394) | Kavo America Corporation | 2005-08-02 |
| D-CARIE, MODEL N121-M1 (K043156) | Neks Technologies, Inc. | 2005-04-28 |
| INSPEKTOR PRO (K040063) | Inspektor Dental Care BV | 2004-06-24 |
| KAVO DIAGNODENT (DEN990002) | Kavo America | 2000-02-22 |
Track NBL automatically
Every clearance here is in the API, with alerts when new ones post.