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510(k) Data Aggregation

    K Number
    K253380

    Validate with FDA (Live)

    Date Cleared
    2026-03-02

    (153 days)

    Product Code
    Regulation Number
    872.3770
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    "FLNT Base" and "FLNT Temp" are used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM.

    Indications for Use:

    • Temporary anterior and posterior crowns;
    • Temporary anterior and posterior bridges;
    • Removable structures for dentures
    Device Description

    "FLNT Base" is a homogeneous polymer material composed of high-quality polymethyl methacrylate (PMMA) and cross-linking agents to improve the network structure through a unique polymerization molding technology. This material is further fabricated into a kind of temporary prosthesis, such as removable dentures. The FLNT Base is composed of PMMA and colorant. Restorations are designed and manufactured by a dental professional using CAD technology.

    "FLNT Temp" is a homogeneous polymer material composed of high-quality polymethyl methacrylate (PMMA) and cross-linking agents to improve the network structure through a unique polymerization molding technology. It is indicated for manufacturing temporary crowns and bridges. Restorations are designed and manufactured by a dental professional using CAD technology.

    "FLNT Base and FLNT Temp" are supplied in different shapes, such as blocks, discs, rods. It is also supplied in different colors, and single or multi-layer aesthetic effect.

    AI/ML Overview

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