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510(k) Data Aggregation

    K Number
    K052710
    Manufacturer
    Date Cleared
    2006-01-13

    (106 days)

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

    VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA

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

    Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.

    For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.

    Device Description

    Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental product called "Vita VM®" (porcelain powder for clinical use).

    The letter confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It discusses regulatory requirements, classifications, and contact information, but it does not detail any specific performance acceptance criteria or a study conducted to demonstrate the device meets such criteria.

    Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.

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