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    K Number
    K241311
    Device Name
    Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
    Manufacturer
    Bernhard Förster GmbH
    Date Cleared
    2024-08-02

    (85 days)

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

    Bernhard Förster GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Thermoforming Sheet Materials Track A, B, E and Bleach are indication 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 patient individual plaster models. After cooling the sheets are removed from the model and trimmed to fit. Thermoforming Sheet Materials include the following products: Thermoforming Sheet Materials: Track A, Track B, Track E, Track bleach.
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