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510(k) Data Aggregation

    K Number
    K020171
    Device Name
    COOLBLU2 DENTAL RESIN CURING DEVICE
    Manufacturer
    DENTAL SYSTEMS.COM, INC.
    Date Cleared
    2002-01-29

    (12 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAL SYSTEMS.COM, INC.

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

    The CoolBlu2 curing light is intended as a source of illumination for the curing of dental restorative materials.

    Device Description

    CoolBlu2 Dental Resin Curing Device

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the CoolBlu2 Dental Resin Curing Device. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested table and details based on the given input. The letter is a regulatory approval document, not a scientific study report.

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    K Number
    K002925
    Device Name
    COOLBLU CURING LIGHT
    Manufacturer
    DENTAL SYSTEMS.COM, INC.
    Date Cleared
    2000-12-20

    (92 days)

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

    DENTAL SYSTEMS.COM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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