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510(k) Data Aggregation

    K Number
    K131799
    Device Name
    QUICKNIT
    Manufacturer
    MICROCOPY, DIV. OF NEO-FLO INC.
    Date Cleared
    2014-01-16

    (211 days)

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

    QUICKNIT

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

    Quicknit Cord is unimpregnated cord for the temporary retraction of the gingival margin. The gingival retraction cord is placed in the sulcus (between the gum tissue and your tooth structure) to displace the gum tissue for a small period of time in dental procedures.

    Professional use is recommended

    Device Description

    Quicknit Cord is unimpregnated cord for the temporary retraction of the gingival margin.

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for a dental device called "Quicknit Cord." It is not a study report or technical document detailing acceptance criteria and performance data for an AI/ML-driven medical device.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies cannot be extracted from the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than presenting a performance study against specific acceptance criteria.

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