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510(k) Data Aggregation

    K Number
    K981526
    Device Name
    ACE ALVEOLAR DISTRACTOR
    Manufacturer
    ACE SURGICAL SUPPLY CO., INC.
    Date Cleared
    1998-11-06

    (192 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ACE Surgical Alveolar Distraction Fixture is designed for use in totally edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE Surgical Alveolar Distractor. This ACE Surgical transitory monofocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions you've asked.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory guidelines.

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