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510(k) Data Aggregation

    K Number
    K974413
    Device Name
    PERMAFLO
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Date Cleared
    1998-02-02

    (70 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PERMAFLO

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

    PermaFlo can be used for:

      1. Anterior and posterior restorations, such as Class I, II, III, IV, and V.
      1. Luting translucent inlays and onlays. Permalute (chemical cure) is recommended for more opaque or thick inlays/onlays where light cure is not predictable.
      1. Direct veneers and other restorative procedures
      1. Restoring missing subgingival tooth structure prior to endodontic procedures (this is referred to as the "donut" technique).
    Device Description

    PermaFlo Flowable Composite

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental product called Permaflo. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets specific acceptance criteria.

    The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. This means it has met the regulatory requirements for market clearance, not that its performance was evaluated against specific quantitative acceptance criteria in a clinical study.

    Therefore, I cannot provide the requested information based on the content of these documents. The request asks for details about a study evaluating device performance, which is not present in this regulatory clearance letter.

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