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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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    K Number
    K152766
    Device Name
    CharmFlex
    Manufacturer
    DENTKIST, INC
    Date Cleared
    2016-03-08

    (166 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTKIST, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Impression material in a dual phase impression technique - Precise duplication of models - Capturing multiple unit impressions
    Device Description
    CharmFlex is impression material. It has 5 types: Putty, Regular, Light, Heavy, Bite. 1) CharmFlex®Putty/ CharmFlex®Putty Green/ CharmFlex®Putty Soft CharmFlex®Putty consists of various Putty-bodies type and dental addition silicone impression material made by polymerization as a mixture of Base and Catalyst. In dental treatment, an impression material used to record oral tissue anatomy. CharmFlex®Putty has viscosity of putty consistency classification according to type 0 ISO 4823 classification. Packaging consists of two putty systems which are supplied by in two jars, the one is base and another is catalyst. This product is used for two step impression and the material for the first impression is for recording oral tissue anatomy. Base and catalyst of impression are packed separatelv 2) CharmFlex®Heavy cartridge type/ CharmFlex®Heavy tube type CharmFlex® Heavy series are hydrophilic vinyl polysiloxane impression materials type of Heavybodies. It is used for the one-step impressions teeth or individual tooth in the mouth. CharmFlex®Heavy as the additional polymerization silicone type is rubber impression materials that registers oral tissue anatomy. It is used with Light-body for impression taking. Packages are cartridge type which is supplied by from of two syringes. This product is used for the first or second impression taking of whole teeth or individual tooth in mouth before the final impression taking. It is silicone based dental rubber impression materials. 3) CharmFlex®Regular/ CharmFlex®Denture/ CharmFlex®Light LV/ CharmFlex®Light XLV/ CharmFlex®Light Premium CharmFlex® Light series are hydrophilic vinyl polysiloxane impression material type of LightLV, Regular and LightXLV. It is used for the one-step or two-step impression taking of teeth or individual tooth in the mouth. CharmFlex® Light XLV/Regular series as the additional polymerization silicone type are rubber impression materials that records oral tissue anatomy. Packages are cartridge type which is supplied by from of two syringes. This product is used for the first or second impression taking of teeth or individual tooth in mouth before the final impression taking. It is silicone based dental rubber impression materials. 4) CharmFlex®Bite/ CharmFlex®Bite Clear/ CharmFlex®Bite Fast CharmFlex Bite series are bite registration impression material to measure of the occlusal surface. impression of the teeth for a three-dimension position of the mandible in relation to the maxilla. It has a short polymerization time and a high final hardness. Making it suitable for bite registration.
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