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510(k) Data Aggregation

    K Number
    K972632
    Device Name
    VERA PD SOLDER
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1997-08-15

    (32 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is a "white" colored, soldering (welding) alloy for use in the construction and repair of crown and bridge dental prostheses.

    Device Description

    This device is a "white" colored, soldering (welding) alloy for use in the construction and repair of crown and bridge dental prostheses.

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a dental solder, Vera PD Solder. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations.

    Based on the provided text, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This letter is a regulatory approval document, not a study report.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test set or data provenance.
    3. Number of experts or their qualifications.
    4. Adjudication method.
    5. MRMC comparative effectiveness study details.
    6. Standalone performance details.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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