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510(k) Data Aggregation

    K Number
    K983515
    Device Name
    KLS INTRAORAL VERTICAL DISTRACTOR
    Manufacturer
    KLS-MARTIN L.P.
    Date Cleared
    1998-11-30

    (54 days)

    Product Code
    MQN
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K973275
    Why did this record match?
    Device Name :

    KLS INTRAORAL VERTICAL DISTRACTOR

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

    The KLS-Martin intra-oral distractor is intended to be used in the conditions of mandibular deficiency or post-traumatic effects of the mandible.

    Device Description

    The KLS Martin Distractor device is designed to distract the mandible in cases of deficiency or post-traumatic effects of the mandible.

    AI/ML Overview

    This document is a 510(k) summary for the KLS Intra-oral Mandibular Distractor. It describes the device, its intended use, and its substantial equivalence to a predicate device (KLS Distractor K973275).

    Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a regulatory submission for premarket notification (510(k)) to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. This type of submission relies on comparison to an existing device rather than presenting new performance data from specific studies with acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance studies.

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