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510(k) Data Aggregation

    K Number
    K254239

    Validate with FDA (Live)

    Device Name
    CyClean Cord
    Manufacturer
    SS GLOBAL
    Date Cleared
    2026-03-27

    (88 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K171577
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CyClean Cord is knitted retraction cord made from 100% lyocell, impregnated with Aluminum Chloride Hexahydrate for the temporary gingival retraction and hemostasis of the gingival margin.

    Device Description

    The CyClean Cord is a dental gingival retraction cord containing aluminum chloride Hexahydrate in 100% lyocell knitted yarn, and is used to temporarily retract gingival tissue prior to obtaining a dental impression, and at the same time remove blood, saliva, and gingival fluid remaining in the gingival hotspots.

    AI/ML Overview

    N/A

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