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510(k) Data Aggregation

    K Number
    K253797

    Validate with FDA (Live)

    Device Name
    One-Stop
    Manufacturer
    Mediclus Co., Ltd.
    Date Cleared
    2026-02-27

    (91 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K162662
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    One-Stop is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation, and cavity preparation.

    Device Description

    One-Stop is a paste-type topical pre-impression agent intended to provide gingival retraction and hemostasis. The product contains aluminum chloride, which functions as an astringent. Its paste consistency allows controlled placement in the target area, and it can be removed by rinsing with water after use.

    AI/ML Overview

    N/A

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