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510(k) Data Aggregation

    K Number
    K982094
    Device Name
    VERABOND 2
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1998-07-22

    (37 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 2

    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

    nonprecious, nickel-chromium-molybdenum based ceramic casting alloy

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental alloy named "VeraBond 2." This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory clearance letter rather than a technical study report.

    Therefore, I cannot provide the requested information from this document. The letter simply states that the FDA has reviewed the device and determined it to be "substantially equivalent" to predicate devices already on the market, thus allowing it to be marketed. It refers to the "indications for use" as stated in an enclosure, but the enclosure itself (which would detail the device's properties and intended use) is not present in the provided text.

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