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510(k) Data Aggregation

    K Number
    K031793
    Device Name
    DENTATUS OSCIOMAT
    Manufacturer
    DENTATUS USA, LTD.
    Date Cleared
    2003-11-13

    (156 days)

    Product Code
    DZH
    Regulation Number
    872.4120
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DENTATUS OSCIOMAT

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

    The Dentatus Osciomat is intended for use in preparing bone in conjunction with dental and craniofacial surgical procedures.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA for a dental device called the "Dentatus Osciomat." It primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance.
    3. Number and qualifications of experts.
    4. Adjudication method.
    5. MRMC comparative effectiveness study.
    6. Standalone performance study.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document is a regulatory approval letter, confirming that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been deemed safe and effective based on existing devices, not necessarily a new clinical study with performance metrics in this specific filing.

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