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510(k) Data Aggregation

    K Number
    K243910
    Device Name
    Retraxil
    Manufacturer
    Date Cleared
    2025-09-24

    (279 days)

    Product Code
    Regulation Number
    N/A
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the temporary displacement of the marginal gingiva and drying of the gingival sulcus, e.g. for

    • conventional or digital impressions,
    • cementation of temporary and permanent restorations
    • and the creation of Class II and V fillings.
    Device Description

    RetraXil belongs to the group of dental retraction material, mainly as cords (threads) with astringent agents. The retraction material is also marketed in form of a paste as alternative to the cords. RetraXil is a retraction paste containing aluminium chloride as astringent agent, which serves as hemostatic agent.

    RetraXil is marketed as a gingival retraction paste with no hints of performance or safety issues for patients and users.

    Retraxil is a retraction paste stored in a 1g syringe with a cannula and twisting aid.

    AI/ML Overview

    N/A

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