LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K090597
    Device Name
    FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH
    Manufacturer
    PASCAL CO., INC.
    Date Cleared
    2009-03-16

    (11 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K030488
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive root surfaces.

    Device Description

    The modified varnish has the following similarities to that which previously received 510(k) concurrence:

    • Has the same active ingredient at the same concentration; .
    • has the same indications for use; .
    • incorporate the same or similar materials; .
    • has the same shelf life, and; ●
    • is packaged using the same materials and processes.
    AI/ML Overview

    I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, study details, or ground truth establishment. The document is primarily a 510(k) summary and an FDA clearance letter for a dental varnish, outlining its substantial equivalence to a predicate device and its indications for use. It does not include the results of a clinical study or performance testing.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1