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510(k) Data Aggregation

    K Number
    K051782
    Device Name
    BLUEPHASE 16I
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2005-09-20

    (81 days)

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

    BLUEPHASE 16I

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

    For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental light-curing device called "Bluephase 16i." It certifies that the device is substantially equivalent to legally marketed predicate devices.

    The letter does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed presentation of performance studies against acceptance criteria.

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