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510(k) Data Aggregation

    K Number
    K093751
    Device Name
    CL-DC20, CL-DC21
    Manufacturer
    GOOD DOCTORS CO., LTD.
    Date Cleared
    2010-02-24

    (79 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CL-DC20, CL-DC21

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CL-DC20 and CL-DC21 Dental Curing Lights are indicated for the curing of dental composites using visible light.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details that would allow me to answer your request. The document is an FDA 510(k) clearance letter for dental curing lights, which confirms the device's substantial equivalence to a predicate device but does not include the detailed study information you've requested.

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