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510(k) Data Aggregation

    K Number
    K980474
    Device Name
    TELICAM
    Manufacturer
    DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    1998-04-13

    (66 days)

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

    TELICAM

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

    Non diagnostic intraoral camera used by dentists to illuminate and magnify dental surfaces.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "Telicam," described as a "Non diagnostic intraoral camera used by dentists to illuminate and magnify dental surfaces." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain any information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

    The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, rather than a demonstration of meeting specific performance criteria through a study described within this document.

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