BEUDAMED
    Product Code: NTK FDA class 2 21 CFR 872.1745

    Caries Detector, Laser Light, Transmission

    Dental

    The Laser Light Transmission Caries Detector is a dental diagnostic device that uses laser light transmitted through tooth structure to detect caries (cavities). It provides a non-invasive method for identifying areas of demineralization or decay in dental hard tissues. It is an FDA Class 2 device regulated under 21 CFR 872.1745 in the Dental specialty, with product code NTK, requiring 510(k) clearance. Third-party review is available. No detailed definition text is provided in the classification record beyond the device name. It is not an implant and does not carry a life-sustaining support flag.

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    510(k)s
    11
    FEI Numbers
    23
    Registration Numbers
    23
    Unique Applicants
    10
    Years Active
    21

    Basic Information

    Product Code
    NTK
    Device Class
    FDA class 2
    Regulation Number
    872.1745
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K250771 Primescan 2
    K240573 iTero Lumina™ Pro
    K213482 TIA Tip, Cariosity, Transillumination Accessory Tip
    K193659 iTero Element 5D
    K182712 DEXIS CariVu 3-in-1 by KaVo
    K172007 CamX Triton HD Proxi Head
    K123402 DIAGNOCAM
    K071429 TI2200 TRANSILLUMINATION CABLE
    K062961 MICROLUX TRANSILLUMINATOR
    K060080 DIAGNODENT 2190 WITH PERIODONTAL PROBE
    K043068 DIFOTI USB 2.0 SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.