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    K Number
    K253365

    Validate with FDA (Live)

    Device Name
    LuxCreo Flexible Partial Denture Resin
    Manufacturer
    Luxcreo, Inc.
    Date Cleared
    2025-11-25

    (56 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K250343,K250617,K250489
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K250343

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

    LuxCreo Flexible Partial Denture Resin is a liquid light-curing resin indicated for the fabrication and repair of partial denture bases. It is intended for use by dental professionals in dental and orthodontic laboratories and clinics.

    LuxCreo Flexible Partial Denture Resin is intended for the additive manufacturing of removable partial denture bases, including denture bases for interim and transitional dentures, for the replacement of one or more missing teeth. The device is supported by remaining natural dentition and oral tissues. Partial dentures manufactured using this resin may be used permanently as a total removable replacement or temporarily while the patient is preparing for permanent implant.

    Device Description

    LuxCreo Flexible Partial Denture (FPD) Resin is a state of the art resin engineered specifically for the 3D Printing of digitally designed flexible partial denture bases. The FPD resin utilizes LuxCreo's Digital Polishing platform to deliver clear, accurate, and biocompatible partial dentures in a single session with minimal need for finishing.

    AI/ML Overview

    N/A

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