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510(k) Data Aggregation

    K Number
    K200125
    Device Name
    Thermoforming Sheet Materials
    Manufacturer
    Erkodent Erich Kopp GmbH
    Date Cleared
    2020-10-28

    (281 days)

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

    Erkodent Erich Kopp GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Thermoforming Sheet Materials are indicated for the fabrication of orthodontic and dental appliances.
    Device Description
    Thermoforming Sheet Materials are pre-shaped flat plastic discs. The sheets are plastified in appropriate thermoforming units and adapted onto patients individual plaster models. After cooling the sheets are removed from the model and trimmed to fit.
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