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510(k) Data Aggregation

    K Number
    K961822
    Device Name
    WET-PREP
    Manufacturer
    BISCO, INC.
    Date Cleared
    1996-06-11

    (32 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VET-PREP is used to re-wet dried dentin following acid etching and drying of the prepared cavity.

    Device Description

    WET-PREP is an aqueous solution of hydroxyethyl methacrylate. Hence, it is an aqueous re-wetting agent (dentin conditioner) that is applied to acid etching tooth structure, by the dentist following prior to application of a hydrophilic dentin adhesive such as ALL-BOND 2. The purpose of WET-PREP is to keep the dental cavity preparation adequately moist before the dentist restores the lost tooth structure.

    AI/ML Overview

    The provided text describes the WET-PREP™ device, its intended use, and scientific rationale, but it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and the detailed study proving device performance in the format you've outlined.

    The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices and generally doesn't include the granular details of a full clinical or performance study report.

    However, I can extract the information that is present and indicate where the requested information is missing.

    Here's an attempt to answer your questions based only on the provided text, with clear indications of missing information:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Implicit Acceptance Criteria (derived from text):
    Re-wet dried dentin and prevent desiccation prior to primer application.WET-PREP significantly improved (greater than four-fold increase) the shear bond strength of air-dried dentin. "Desiccated dentin could be reconstituted so no significant difference could be found between treated teeth and those that were handled in a clinically acceptable fashion."
    Not significantly interfere with the bonding mechanism of primer resins and the prepared tooth."There was no statistically significant difference (p=0.05, t=1.29) between the shear bond strength of WET-PREP treated teeth and those left untreated."
    Improve shear bond strength compared to predicate HEMA-BENZ."WET-PREP treated teeth were found to have significantly greater shear bond strength when compared to HEMA-BENZ treated teeth (p=0.5 [sic, likely typo, should be
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