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510(k) Data Aggregation

    K Number
    K211554
    Device Name
    InnoGenic Non-resorbable Membrane
    Manufacturer
    Cowellmedi Co., Ltd.
    Date Cleared
    2023-02-24

    (646 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    InnoGenic Non-resorbable Membrane

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

    InnoGenic™ Non-resorbable membrane is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called "InnoGenic™ Non-resorbable Membrane". This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment related to an AI/ML powered medical device.

    The document states that the device is a "temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites." It is a Class II device (Bone Grafting Material, 21 CFR 872.3930).

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

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