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510(k) Data Aggregation

    K Number
    K972533
    Device Name
    VERA SOLDER
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1997-09-05

    (60 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VERA SOLDER

    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 prosthetic devices. According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.

    Device Description

    "White" Colored, Soldering (Welding) Alloy

    AI/ML Overview

    The provided text is a 510(k) cleared letter from the FDA for a dental soldering alloy. It does not contain information regarding an AI/ML medical device, clinical study, or acceptance criteria.

    Therefore, I cannot answer the questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth.

    The document pertains to the clearance of a physical material (dental alloy) and confirms its substantial equivalence to pre-amendment devices, under general controls provisions of the Act.

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