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510(k) Data Aggregation

    K Number
    K250739

    Validate with FDA (Live)

    Date Cleared
    2025-11-07

    (241 days)

    Product Code
    Regulation Number
    872.5470
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K232448

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

    Primeprint Aligner is a light curing resin intended for the treatment of tooth malocclusion in patients with developed permanent dentition. Primeprint Aligner repositions teeth by way of continuous gentle force.

    Intended place of use: Orthodontic/dental practices/clinics, dental laboratories

    Device Description

    Primeprint Direct Aligner is a light-curing material for the production of aligners using the Primeprint Solution (Primeprint 385nm DLP 3D printer and Primeprint Post Processing Unit). The material is intended for the treatment of tooth malocclusion in patients with developed permanent detention. Primeprint Direct Aligner repositions teeth by way of continuous gentle force.

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    K Number
    K252430

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-10-30

    (90 days)

    Product Code
    Regulation Number
    872.3760
    Panel
    Dental
    Reference & Predicate Devices
    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.

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