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510(k) Data Aggregation

    K Number
    K030052
    Device Name
    OSTIM
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2004-12-06

    (700 days)

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

    OSTIM

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

    Ostim is intended as a filling or reconstruction material for repair of bony defects in oral, gnathic and facial applications in the following indications:

    • Filling of intraoral bony defects such as those resulting from cytectomies, tooth tip I resections, extractions or surgical tooth removal.
    • Augmentations in the area of the alveolar processes and maxillary sinuses.
    • Filling of periodontal defects.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or the other specific points requested in your prompt. The document is a 510(k) clearance letter from the FDA for a bone grafting material called Ostim®, outlining its regulatory status and intended use, but it does not include a scientific study or performance data table.

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