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510(k) Data Aggregation

    K Number
    K983104
    Device Name
    NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
    Manufacturer
    NORIAN CORP.
    Date Cleared
    1999-02-12

    (161 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K962548,K973789
    Why did this record match?
    Device Name :

    NORIAN PERIODONTAL/DENTAL CEMENT (PDC)

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

    Norian PDC is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall.

    Norian PDC Cement is intended to be used in the treatment of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.

    Device Description

    Norian PDC is a paste-like bone cement which is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall. Norian PDC is an injectable and moldable, biocompatible, bone cement. The Norian PDC Reactants Pack contains the two sterile components used in Norian PDC: Calcium Phosphate Powder and Sodium Phosphate Solution. The Reactants Pack is mixed in a pneumatic mixer to form a smooth, viscous paste which is applied to the operative site. Norian PDC cures into a carbonated apatite that is substantially similar to the mineral component of bone, and over time, the Norian PDC is gradually resorbed over time.

    AI/ML Overview

    The provided text is a 510(k) summary for the Norian® PDC™ bone cement. It describes the device, its intended use, and device testing. However, it does not contain the detailed information needed to answer the specific questions about acceptance criteria for a device's performance, a specific study proving it, or AI/human reader performance.

    The document states: "Biocompatibility testing showed that Norian PDC Cement is acceptable for its intended use as a bone implant material. Norian Cement passed all tests, and showed no toxic, mutagenic or irritating effect." This is a general statement about meeting biocompatibility requirements, not specific performance metrics (like accuracy, sensitivity, specificity) for a diagnostic or AI-based device, nor details of a study with human readers.

    Therefore, I cannot provide the requested information based on the provided text. The questions are geared towards the evaluation of AI/diagnostic devices, which is not the subject of this 510(k) summary for a bone cement.

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