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510(k) Data Aggregation

    K Number
    K163613
    Device Name
    Bluephase Style 20i
    Manufacturer
    IVOCLAR VIVADENT, AG
    Date Cleared
    2017-04-04

    (103 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Abbreviated
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K091020
    Why did this record match?
    Reference Devices :

    K091020

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

    With its "Polywave" broadband spectrum, Bluephase® Style 20i is suitable for the polymerization of all light curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.

    Device Description

    Bluephase® Style 20i is an LED polymerization light that produces energy-rich blue plight. It is used for the polymerization of light-curing dental materials immediately at the dental unit. It consists of 1 Polywave LED in the probe.

    • The handpiece has the shape of a pen
      Operational notes: 2 programs (Turbo, High Power)
      Light source: Polywave LED
      Power source: Li-Po battery
    AI/ML Overview

    The provided text is a 510(k) premarket notification for a medical device called "Bluephase Style 20i," a dental light-curing unit. It does not contain specific details about acceptance criteria, device performance tables, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for an AI/ML-based medical device.

    The document primarily focuses on establishing substantial equivalence to a predicate device (Bluephase 20i) based on:

    • Indications for Use: Both devices are for polymerization of light-curing dental materials.
    • Working Principle: Both use an LED polymerization light to cure dental materials.
    • Material Composition: Stated as "No difference."
    • Electrical Safety: Both conform to the same IEC standards.
    • Biocompatibility: Stated that construction materials are substantially the same as the predicate.
    • Software Validation: Mentions full validation and adherence to FDA guidance, but no performance metrics.
    • Bench Testing: Confirmed the heat sink switch-off temperature met design specifications.

    The document is a regulatory submission for a physical device, not an AI/ML software as a medical device. Therefore, the information requested in your prompt regarding AI/ML device testing (e.g., ground truth, MRMC studies, standalone performance) is not applicable or present in this document.

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