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510(k) Data Aggregation

    K Number
    K102341
    Device Name
    VIPI BLOCK
    Manufacturer
    VIPI INDUSTRIA,COMERCIO,EXPORTACAO E IMPORTACAO DE
    Date Cleared
    2010-12-16

    (120 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIPI INDUSTRIA,COMERCIO,EXPORTACAO E IMPORTACAO DE

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

    The VIPI Block is a PMMA blank for manufacturing temporary crowns and bridges by a CAD/CAM system.

    Device Description

    The VIPI Block is a PMMA blank for manufacturing temporary crowns and bridges by a CAD/CAM system.

    AI/ML Overview

    This looks like a 510(k) clearance letter for a dental device, specifically a PMMA blank for manufacturing temporary crowns and bridges. This document does not contain the type of information requested about acceptance criteria and study details for an AI/ML powered medical device.

    The document confirms that the device, VIPI Block, is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about test set sample size, provenance, or ground truth establishment.
    • Information on expert validation, adjudication methods, or MRMC studies.
    • Any mention of AI or machine learning algorithms.

    Therefore, I cannot fulfill your request using the provided text.

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