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510(k) Data Aggregation

    K Number
    K990511
    Device Name
    X-TIP INTRAOSSEOUS PERFORATOR
    Manufacturer
    SCHIFF & CO.
    Date Cleared
    1999-04-27

    (68 days)

    Product Code
    DZM
    Regulation Number
    872.4730
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    DZM

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

    The X-TIP Intraosseous Perforator is intended as a disposable delivery apparatus and method for intraosseously delivering dental anesthesia in a simple, safe and effective manner directly into cancellous bone.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the X-TIP Intraosseous Perforator. It primarily addresses the regulatory approval process and states the device's intended use. It does not contain any information regarding specific acceptance criteria for device performance or a study proving that the device meets such criteria.

    Therefore, I cannot provide the requested information. The letter only confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not detail performance data or studies.

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