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510(k) Data Aggregation

    K Number
    K980151
    Device Name
    RELEASABLE FORCE MODULE
    Manufacturer
    ORTHO KINETICS CORP.
    Date Cleared
    1998-04-06

    (80 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to be used for the prescribed treatment of malocclusions by dentists.

    Device Description

    Self-Releasable Force Module

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, and ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for a device called "Releasable Force Module," indicating its substantial equivalence to a predicate device. It does not include specific performance data or details of a study that proves the device meets acceptance criteria.

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