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510(k) Data Aggregation

    K Number
    K973257
    Device Name
    VERSAETCH
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    1997-11-17

    (80 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Touth etchant And conditioners to took surface for Second's, then Rinse off 20 Proceed to Apply water. specific manda Agents As per INSTRUctions,

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device named "Versa Etch." It primarily details the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding specific acceptance criteria, performance data, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. It is a regulatory approval notice, not a technical performance report.

    Therefore, I cannot provide the requested information based on the input document.

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