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510(k) Data Aggregation

    K Number
    K244006
    Device Name
    FG Bone Graft M
    Manufacturer
    Full Golden Biotech Co., Ltd.
    Date Cleared
    2025-09-17

    (265 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K051885
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FG Bone Graft M is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.

    These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

    Typical uses include:

    • Periodontal/Intrabony defects filling
    • Ridge augmentation
    • Implant preparation, placement in extraction sites
    • Sinus lifts
    • Cystic cavities filling
    Device Description

    The Synthetic Bone Substitute, FG Bone Graft M, is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (β-TCP).

    The synthetic bone substitute is presented in a porous form required for the conduction of precursor cells to the defect site to facilitate new bone growth.

    This product is provided sterile for single patient use.

    The synthetic bone substitute is progressively replaced by new bone according to the remodeling process.

    AI/ML Overview

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