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510(k) Data Aggregation

    K Number
    K153493
    Device Name
    Clip Flow
    Manufacturer
    VOCO GmbH
    Date Cleared
    2016-07-29

    (238 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Clip Flow

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

    [A] Temporary inlay and onlay treatments of the cavity [B] Sealing of openings for implant screws [C] Relining material for temporary crowns and bridges [D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions [E] Covering of the gingival margin [F] Fixing of resin matrix during filling placement [G] Temporary filling of cavities

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental device called "Clip Flow". It addresses the regulatory aspects of the device and its indications for use, but it does not contain any information regarding acceptance criteria, study details, or performance data of the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on this document. The document primarily confirms the substantial equivalence of the device to a predicate device for its stated indications for use.

    To answer your questions, I would need access to the actual 510(k) submission or related performance studies, which are not included in the provided text.

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