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    K Number
    K241283
    Device Name
    Elemental Granulate
    Manufacturer
    Zinkh NV
    Date Cleared
    2025-01-03

    (241 days)

    Product Code
    OLR, EMA
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zinkh NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elemental Granulate is a periodontal wound dressing intended to protect injured periodontal tissue as surgical sites.
    Device Description
    Elemental Granulate is a thermoplastic and non-resorbable medical device, which under in vitro conditions is found to be bacteriostatic. Material consistency is plastic-like and highly moldable after heating. Hardening starts 30 to 60 seconds after taking it away from the heat source. Hardens into a rigid material after approximately 90 seconds. Individual granules may slightly differ in size. For use only by a dental professional in the recommended indications.
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