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510(k) Data Aggregation

    K Number
    K983847
    Device Name
    MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT
    Manufacturer
    GERMIPHENE CORP.
    Date Cleared
    1998-12-01

    (32 days)

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

    MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT

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

    The Odyssey ITM Dental Water unit with CAT filter is indicated for use as an in-line water disinfecting system to reduce microorganisms and particulate matter in the dental waterline.

    Device Description

    Odyssey ITM Dental Water unit

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document describes a 510(k) premarket notification for a dental water unit and focuses on regulatory approval rather than a study about the device's performance or acceptance criteria.

    The document does not contain:

    • A table of acceptance criteria and reported device performance.
    • Information about sample sizes, data provenance, or details of a test set.
    • The number or qualifications of experts used to establish ground truth.
    • Adjudication methods.
    • Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
    • Details about a standalone algorithm performance study.
    • The type of ground truth used.
    • The sample size for a training set.
    • How ground truth for a training set was established.
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