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510(k) Data Aggregation

    K Number
    K122955
    Device Name
    DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
    Manufacturer
    WRIGHT HEALTH GROUP LTD.
    Date Cleared
    2013-03-01

    (157 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    WRIGHT HEALTH GROUP LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These dental plastic teeth are parts used for denture fabrication. PMMA is mixed with monomer in a polymenzation process. The plastic teeth are part of dentures made to fit a patient's mouth which are removable or may be attached to dental implant devices.
    Device Description
    The synthetic plastic teeth are used in the production of dentures. They are produced from a I he synuletic process. Polymethylmethacrylate or PMMA is mixed with methylmethacrylate monomer, a cross linking agent and non-toxic pigments under heat and pressure. Once the monomer, a cross iniking agoit and non teen are checked for flash and polished according to the relevant model characteristics.
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