NBL — Light-Induced Fluorescence Caries Detector Class II
FDA product code NBL covers "Light-Induced Fluorescence Caries Detector", a Class II medical device regulated under 21 CFR 872.1745. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NBL
- Device Class
- Class II
- Regulation Number
- 872.1745
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252464 | zumax medical co | Surgical Microscope (OMS2360, OMS2380) | April 28, 2026 |
| K242103 | 3shape trios | TRIOS Ready Tip | April 4, 2025 |
| K221275 | aiobio co | Qraycam PRO | September 4, 2024 |
| K231722 | smartooth co | SmarTooth | May 1, 2024 |
| K223470 | sopro | C50 | December 14, 2023 |
| K221249 | 3shape trios | L1P-1F (TRIOS 5) | September 16, 2022 |
| K183471 | good doctors co | IC-WHCD100 (Inspire) | July 2, 2020 |
| K171007 | carl zeiss suzhou co | Fluorescence Mode | May 3, 2018 |
| K170822 | ortek therapeutics | Electronic Caries Detector | September 11, 2017 |
| K150672 | durr dental | VistaCam iX Proof | January 27, 2016 |
| K121685 | sopro | SOPROCARE | March 12, 2013 |
| K112139 | quantum dental technologies | THE CANARY SYSTEM | October 26, 2012 |
| K111423 | carestream health | CS 1600 INTRAORAL CAMERA | March 2, 2012 |
| K111321 | cariescan | REMOTE VIEW SOFTWARE | May 17, 2011 |
| K093705 | therapeutic technologies | FUORECAM | April 23, 2010 |
| K092583 | sopro | SOPROLIFE | January 13, 2010 |
| K090598 | cariescan | CARIESCAN PRO | December 15, 2009 |
| K090169 | air techniques | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE | August 18, 2009 |
| K063321 | neks technologies | D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 | March 30, 2007 |
| K051909 | kavo america | DIAGNODENT | October 21, 2005 |