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510(k) Data Aggregation

    K Number
    K132526
    Device Name
    KNIT-PAK+
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2013-11-26

    (106 days)

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

    KNIT-PAK+

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

    Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord is used for temporary chemo-mcchanical retraction of gingival tissues and hemostasis of the gingival margin around the tooth. It is intended for accurate and enhanced results when acquiring dental impressions, for cavity preparation or wherever hemostasis and retraction is required.

    Device Description

    Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Knit-Pak+". This document is a regulatory approval letter and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It also outlines regulatory responsibilities for the company.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The requested information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not present in this document.

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