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510(k) Data Aggregation

    K Number
    K112716
    Device Name
    OSTEON II
    Manufacturer
    GENOSS CO., LTD.
    Date Cleared
    2012-01-17

    (120 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K062834
    Why did this record match?
    Reference Devices :

    K062834

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

    OSTEON II is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.

    • Periodontal/Infrabony defects
    • Ridge augmentation
    • Extraction sites (implant preparation/placement)
    • Sinus lifts
    • Cystic cavities
    Device Description

    This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP). This product presents an interconnected porous structure, similar to that of human cancellous bone. This product is available as irregular shaped particles of size 0.2~2.0 mm. It is supplied sterile by gamma irradiation.

    AI/ML Overview

    The provided document describes the OSTEON II device, a synthetic bone grafting material. It outlines the device's characteristics, indications for use, and performance data for biocompatibility and bench testing. However, it does not include specific acceptance criteria or a study designed to demonstrate that the device meets those criteria, especially in terms of diagnostic performance or clinical effectiveness.

    The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (OSTEON) based on similar materials, indications for use, and design.

    Here's an breakdown of the information that is available and what is missing based on your prompt:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Explicitly Stated)Reported Device Performance
    Biocompatibility:
    ISO CytotoxicityMet standards
    ISO PyrogenicityMet standards
    ISO Intracutaneous reactivityMet standards
    ISO AmesMet standards
    ISO Systemic toxicityMet standards
    ISO SensitizationMet standards
    ISO ImplantationMet standards
    ISO Micro-nucleusMet standards
    Performance Bench Testing:
    -Ca/P ratioMet established specifications
    -Crystalline Phase CompositionsMet established specifications
    -PorosityMet established specifications
    -Water Solubility TestMet established specifications
    -DensityMet established specifications
    -Crystallinity ValueMet established specifications

    Missing: The document does not provide numerical acceptance criteria for any of these tests (e.g., "Cytotoxicity score must be

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