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510(k) Data Aggregation

    K Number
    K980436
    Device Name
    CLASS III REVERSE PULL FACEMASK
    Manufacturer
    ORTHO KINETICS CORP.
    Date Cleared
    1998-04-27

    (82 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CLASS III REVERSE PULL FACEMASK

    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. The device is to be used to provide anchorage in Class 3 malocclusion case treatment.

    Device Description

    Class III+™ Reverse Pull Facemask

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, approving the Ortho Kinetics Corporation's "Class III Reverse Pull Facemask." It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter confirms that the device is substantially equivalent to legally marketed devices prior to May 28, 1976, and outlines regulatory requirements for marketing.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

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