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510(k) Data Aggregation

    K Number
    K183598
    Device Name
    KeyPrint KeySplint Soft
    Manufacturer
    Keystone Industries
    Date Cleared
    2019-11-15

    (324 days)

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

    KeyPrint KeySplint Soft

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

    The KeyPrint® KeySplint Soft™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

    The letter primarily focuses on:

    • Confirming that the device (KeyPrint KeySplint Soft) is substantially equivalent to legally marketed predicate devices.
    • Outlining regulatory requirements and general controls that the manufacturer must adhere to.
    • Stating the intended indications for use of the device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from the provided text.

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