Laser, Fluorescence Caries Detection
The Fluorescence Caries Detection Laser is a dental diagnostic device that uses laser-induced fluorescence to identify and quantify dental caries (tooth decay) in its early stages before it becomes visible to the naked eye, allowing for early intervention and conservative treatment. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 872.1745 (Dental specialty).
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Basic Information
- Product Code
- NBL
- Device Class
- FDA class 2
- Regulation Number
- 872.1745
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 24 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252464 | Surgical Microscope (OMS2360, OMS2380) | Apr 28, 2026 | Substantially Equivalent | Zumax Medical Co., Ltd. |
| K242103 | TRIOS Ready Tip | Apr 04, 2025 | Substantially Equivalent | 3Shape TRIOS A/S |
| K221275 | Qraycam PRO | Sep 04, 2024 | Substantially Equivalent | AIOBIO Co., Ltd. |
| K231722 | SmarTooth | May 01, 2024 | Substantially Equivalent | Smartooth Co., Ltd. |
| K223470 | C50 | Dec 14, 2023 | Substantially Equivalent | Sopro |
| K221249 | L1P-1F (TRIOS 5) | Sep 16, 2022 | Substantially Equivalent | 3Shape TRIOS A/S |
| K183471 | IC-WHCD100 (Inspire) | Jul 02, 2020 | Substantially Equivalent | Good Doctors Co., Ltd. |
| K171007 | Fluorescence Mode | May 03, 2018 | Substantially Equivalent | Carl Zeiss Suzhou Co., Ltd. |
| K170822 | Electronic Caries Detector | Sep 11, 2017 | Substantially Equivalent | Ortek Therapeutics, Inc. |
| K150672 | VistaCam iX Proof | Jan 27, 2016 | Substantially Equivalent | Durr Dental AG |
| K121685 | SOPROCARE | Mar 12, 2013 | Substantially Equivalent | Sopro |
| K112139 | THE CANARY SYSTEM | Oct 26, 2012 | Substantially Equivalent | Quantum Dental Technologies, Inc. |
| K111423 | CS 1600 INTRAORAL CAMERA | Mar 02, 2012 | Substantially Equivalent | Carestream Health, Inc. |
| K111321 | REMOTE VIEW SOFTWARE | May 17, 2011 | Substantially Equivalent | Cariescan , Ltd. |
| K093705 | FUORECAM | Apr 23, 2010 | Substantially Equivalent | Therapeutic Technologies, Inc. |
| K092583 | SOPROLIFE | Jan 13, 2010 | Substantially Equivalent | Sopro |
| K090598 | CARIESCAN PRO | Dec 15, 2009 | Substantially Equivalent | Cariescan , Ltd. |
| K090169 | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE | Aug 18, 2009 | Substantially Equivalent | Air Techniques, Inc. |
| K063321 | D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 | Mar 30, 2007 | Substantially Equivalent | Neks Technologies, Inc. |
| K051909 | DIAGNODENT | Oct 21, 2005 | Substantially Equivalent | Kavo America |
| K042394 | DIAGNODENT PERIO TIP (ACCESSORY) | Aug 02, 2005 | Substantially Equivalent | Kavo America Corporation |
| K043156 | D-CARIE, MODEL N121-M1 | Apr 28, 2005 | Substantially Equivalent | Neks Technologies, Inc. |
| K040063 | INSPEKTOR PRO | Jun 24, 2004 | Substantially Equivalent | Inspektor Dental Care BV |
| DEN990002 | KAVO DIAGNODENT | Feb 22, 2000 | Unknown | Kavo America |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.