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510(k) Data Aggregation

    K Number
    K973265
    Device Name
    VERABOND 2V
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1997-10-16

    (48 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VERABOND 2V

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

    This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge 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

    This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a dental alloy, Verabond 2V. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The information requested in the prompt, specifically related to acceptance criteria and a study proving the device meets those criteria, is not present in the provided document.

    This letter is a regulatory approval notice based on substantial equivalence, not a detailed report of a clinical or performance study with specific acceptance criteria.

    Therefore, I cannot provide the requested table and study details.

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