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510(k) Data Aggregation

    K Number
    K152861
    Device Name
    Aquasil Ultra + Smart Wetting Impression Material
    Manufacturer
    DENTPLY INTERNATIONAL INC.
    Date Cleared
    2016-03-04

    (156 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTPLY INTERNATIONAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aquasil® Ultra + Smart Wetting® Impression Material is indicated for all dental impression techniques.
    Device Description
    Aquasil® Ultra+ Smart Wetting® Impression Material is a quadrafunctional hydrophilic addition reaction silicone elastomeric dental impression material with excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation.
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