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510(k) Data Aggregation

    K Number
    K973248
    Device Name
    IMTEC BONE COLLECTOR SYSTEM
    Manufacturer
    IMTEC CORP.
    Date Cleared
    1997-11-19

    (82 days)

    Product Code
    EHZ,EZH
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K971036
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IMTEC Bone Collector System is designed to facilitate the collection of autogenous bone particles for use in augmentation procedures. This is accomplished by introducing into the surgical suction line a housing and filter apparatus. Autogenous bone particles which would otherwise be loss into the suction system are trapped in this filter. This material may be easily retrieved for usage.

    Device Description

    The IMTEC Bone Collector System is designed to facilitate the collection of autogeneous bone for use in augmentation procedures. Adapted from an oral suction device it contains a filter cartridge which traps bone particles resulting from drilling into bone. The filter can be removed and the bone particles asceptically collected. The filters are available either sterile/single use or autoclavable. The autoclavable filter cartridge is not recommended for reuse in bone collection augmentation procedures.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the IMTEC Bone Collector System, primarily focusing on its description, indications for use, materials, and substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested table or details about a study.

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