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510(k) Data Aggregation

    K Number
    K250512

    Validate with FDA (Live)

    Device Name
    Augmented Gingival Matrix
    Manufacturer
    Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
    Date Cleared
    2025-12-05

    (287 days)

    Product Code
    NPL
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K210280
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is indicated for localized gingival augmentation to increase keratinized tissue (KT) around teeth.

    Device Description

    AGM is a three-layer, symmetrical composite matrix intended for oral tissue regeneration. The top and bottom of the product are gelatin layers, which are made of gelatin derived from bovine bone. The gelatin layers are structured as random fiber stacking by in situ cross-linked electrospinning technology and its average diameter is 100 - 900 nm. Users do not need to distinguish between the top and bottom of the product. The middle of the product is polycaprolactone layer (Abbreviated as "PCL layer"), which is thin polycaprolactone film with porous structure.

    When adhering to the wound surface, the "inner" gelatin layer, the one facing the wound can increase keratinized tissue (KT) around teeth. The middle of PCL layer promotes the spreading of matrix on wound surface. Along with the "outer" gelatin layer, the PCL layer also acts as physical barrier to prevent foreign objects' invasion.

    AI/ML Overview

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