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510(k) Data Aggregation

    K Number
    K022408
    Device Name
    CEREC VITABLOCKS MK2
    Manufacturer
    B.B.'S PROPHY SHOP
    Date Cleared
    2002-09-06

    (44 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CEREC VITABLOCKS MK2

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

    Production of ceramic inlays, onlays, veneers, crowns & bridges using the Cerec machine

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental device called "VITABLOCS® Mark II," identified by the 510(k) number K022408. This document does not contain information about acceptance criteria, device performance studies, or details relevant to AI/ML device evaluations.

    Specifically, it is a notification of substantial equivalence for a porcelain powder for clinical use (ceramic blocks for dental restorations). The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) from this document. This kind of information is typically found in a comprehensive premarket notification (510(k)) submission, not in the FDA's clearance letter itself.

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