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    K Number
    K252430
    Device Name
    Freeprint® denture flex
    Manufacturer
    detax GmbH
    Date Cleared
    2025-10-30

    (90 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K213994,K232448,K200461
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K213994, K232448

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

    The Freeprint® denture flex is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment. The Freeprint® denture flex is indicated for the fabrication, by additive manufacturing, of dental objects such as flexible partial removable dentures.

    Device Description

    Freeprint® denture flex is a light-cured, 3D printed flexible denture resin. The Subject device is used by a dental professional (dentist or dental technician) in the CAD/CAM manufacturing of patient-specific partial dentures. There are two models of the Subject device which are referred to as Freeprint® denture flex clear and Freeprint® denture flex pink-transparent. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigment and is provided in an HDPE bottle.

    The Subject device resin is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are one-time use, prescription-only devices.

    AI/ML Overview

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