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510(k) Data Aggregation

    K Number
    K170245
    Device Name
    DSM Biomedical Dental Bone Graft
    Manufacturer
    Kensey Nash Corporation dba DSM Biomedical
    Date Cleared
    2017-05-16

    (110 days)

    Product Code
    NPM
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K033815
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DSM Biomedical Dental Bone Graft is indicated for:

    • Augmentation or reconstructive treatment of the alveolar ridge
    • Filling of infrabony periodontal defects
    • Filling of defects after root resection, apicoectomy, and cystectomy
    • Filling of extraction sockets to enhance preservation of the alveolar ridge
    • Elevation of the maxillary sinus floor
    • Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
    • Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
    Device Description

    The DSM Biomedical Dental Bone Graft is a non-pyrogenic porous bone mineral matrix for use in periodontal, oral, and maxillofacial surgery. It is produced by removing organic components from porcine bone. The composition of DSM Biomedical Dental Bone Graft meets the requirements of ASTM F 1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is provided as cancellous granules approximately 0.25 - 1.0mm in size. It is supplied sterile by gamma irradiation and is for single use only.

    AI/ML Overview

    The provided text is a 510(k) summary for the DSM Biomedical Dental Bone Graft. It describes the device, its indications for use, and a comparison to a predicate device (Bio-OSS®). However, this document does not contain the acceptance criteria or a study proving that an AI device meets acceptance criteria.

    Instead, it pertains to a traditional medical device (a dental bone graft material) and focuses on demonstrating substantial equivalence to a predicate device through material characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study.

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device's performance based on the provided text. The document does not describe an AI device.

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