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510(k) Data Aggregation

    K Number
    K151542
    Device Name
    A-Oss
    Manufacturer
    HIOSSEN INC.
    Date Cleared
    2016-08-03

    (422 days)

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

    A-Oss® is applicable in filling of the bone defect and bone augmentation in the following dental areas.

    • Filling in the missing part of a bone due to periodontal disease, cystectomy, or dental extraction
    • Filling in the missing part of a bone surrounding an implant
    • Maxillary sinus lift for implant
    • Alveolar bone augmentation/restoration
    Device Description

    Bone Grafting Material

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Hiossen Inc. regarding their device, A-Oss®. It confirms substantial equivalence to predicate devices but does not contain information about acceptance criteria, device performance testing, or study details.

    Therefore, I cannot extract the requested information regarding design verification, validation, and performance studies. The document primarily focuses on regulatory approval and compliance.

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