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510(k) Data Aggregation

    K Number
    K193496
    Device Name
    CharmFil
    Manufacturer
    Dentkist, Inc.
    Date Cleared
    2020-05-06

    (141 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dentkist, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CharmFil is indicated for following restorative applications. 1. Class I, II, V restorations of posterior teeth 2. Class III, IV, V restorations of anterior teeth 3. Cervical cavities or defects involving root surfaces
    Device Description
    This device is light curing dental for dental surgery treatment and type 1, class 2, group 1 according to ISO 4049 classification. It is made in the form of paste and filled in syringe. When you use the product, press out the content in the syringe by screw. It is used to restore a cavity as taking out from it as much as you need with an instrument. It is dental filling material for restoring the cavities.
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