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510(k) Data Aggregation

    K Number
    K982480
    Device Name
    PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.
    Manufacturer
    DENTALVIEW, INC.
    Date Cleared
    1998-09-15

    (61 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.

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

    The PerioView Model DV-1 Fiberscope and Window Sheath is intended to be used with the PerioView family of dental instruments in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath the intact gum line within the oral cavity.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter for a medical device (PerioView Model DV-1 Fiberscope and Window Sheath), but it does not contain any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter primarily focuses on:

    • Confirming the substantial equivalence of the device to legally marketed predicates.
    • Outlining regulatory responsibilities and contacts.
    • Stating the intended indications for use.

    Therefore, I cannot extract the specific technical details about device performance tests and validation studies from this document.

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