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510(k) Data Aggregation

    K Number
    K053392
    Device Name
    FUTURABOND NR SINGLE DOSE
    Manufacturer
    VOCO GMBH
    Date Cleared
    2005-12-15

    (10 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FUTURABOND NR SINGLE DOSE

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

    Futurabond NR Single Dose is intended to be applied onto the interior of a prepared Futurabond NR Single Dood is internation of a restoration.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental bonding agent, Futurabond NR Single Dose. It does not contain the acceptance criteria or reported device performance data. Therefore, I cannot provide the requested information.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the clearance is based on substantial equivalence to existing devices, not necessarily a new study proving the device meets specific acceptance criteria outlined in the letter itself.

    To find the information you're looking for, you would typically need to refer to the 510(k) submission document itself, or potentially a separate clinical study report if one was conducted and referenced within the submission.

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