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510(k) Data Aggregation

    K Number
    K973492
    Device Name
    DENTALVIEW PERIOVIEW SYSTEM
    Manufacturer
    DENTALVIEW, INC.
    Date Cleared
    1997-10-21

    (36 days)

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

    DENTALVIEW PERIOVIEW SYSTEM

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

    The PerioView system by DentalView is a system intended for use in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath an intact gumline within the oral cavity.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called the "Dentalview Perioview System." It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information. The letter primarily focuses on regulatory approval based on substantial equivalence, not on the detailed technical data typically found in a study summary or clinical trial report.

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