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510(k) Data Aggregation

    K Number
    K013993
    Device Name
    NEOCALEX
    Date Cleared
    2002-02-22

    (80 days)

    Product Code
    Regulation Number
    872.4565
    Why did this record match?
    Applicant Name (Manufacturer) :

    STEPHEN M KORAL, DMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Neocalex is indicated for the following uses in dentistry: 1. root canal filling 2. apexification 3. direct pulp cap 4. indirect pulp cap
    Device Description
    Not Found
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