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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
    Predicate For
    N/A
    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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    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
    Predicate For
    N/A
    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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