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510(k) Data Aggregation

    K Number
    K200580
    Device Name
    FotoDent denture
    Manufacturer
    Dreve Dentamid GmbH
    Date Cleared
    2020-11-19

    (259 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dreve Dentamid GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FotoDent® denture is a light curing resin intended for manufacturing of full and partial removable dentures.
    Device Description
    FotoDent® denture is a light curable resin for 3D printing of full and partial dentures.
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    K Number
    K190571
    Device Name
    StoneBite and StoneBite scan
    Manufacturer
    Dreve Dentamid GmbH
    Date Cleared
    2019-11-07

    (246 days)

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

    Dreve Dentamid GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StoneBite® and StoneBite® scan are addition-curing silicones for bite registrations. StoneBite® is indicated for: - bite registrations - I key for intraoral registration StoneBite® scan is indicated for: - i bite registrations - key for intraoral registration - . optical collection of data in CAD/CAM/CIM systems
    Device Description
    StoneBite and StoneBite scan are addition-curing silicones for bite registration, used in dental applications to produce an accurate reproduction of the patient's occlusal record. StoneBite and StoneBite scan are vinyl polysiloxane based materials. StoneBite and StoneBite scan are medium-body elastomeric bite registration materials for dental applications to produce an accurate reproduction of the patient's occlusal record. StoneBite and StoneBite scan are two-component (base and catalyst) additioncuring materials.
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    K Number
    K171562
    Device Name
    Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
    Manufacturer
    Dreve Dentamid GmbH
    Date Cleared
    2018-04-13

    (318 days)

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

    Dreve Dentamid GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dynax® Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
    Device Description
    Dynax® Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal and dental implant. Base and catalyst components are mixed in equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.
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    K Number
    K162408
    Device Name
    Nano Varnish, Plaquit, Lightpaint on Surface
    Manufacturer
    DREVE DENTAMID GMBH
    Date Cleared
    2018-04-05

    (584 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Why did this record match?
    Applicant Name (Manufacturer) :

    DREVE DENTAMID GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Varnish for final coating for resin temporaries to produce a smooth and shiny surface.
    Device Description
    The light-curing one-component dental sealing lacquers NanoVarnish, Plaquit and Lightpaint on Surface are designed for coating resin parts of complete and partial dental prosthesis and for provisional crowns and bridges. The lacquer is applied to a dental restoration and cured with the help of a dental light-curing unit.
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    K Number
    K171729
    Device Name
    Fixtemp C&B
    Manufacturer
    Dreve Dentamid GmbH
    Date Cleared
    2017-12-13

    (184 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dreve Dentamid GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fixtemp® C&B is a resin based material used to fabricate temporary crowns and bridges.
    Device Description
    Fixtemp® C&B is a two-component automatically mixable composite on the basis of multifunctional (meth)acrylates provided in standard double cartridges. The material is dispensed and mixed by cartridge/mixing tip combination and it is used for the manufacturing of temporary crowns and bridges for use until the permanent restoration is fabricated. It can be also used for inlays, onlays and veneers and is available in tooth-colors A1, A2, A3, A3.5, B1, Bleach X and D2. This is a prescription only material. The labeling and working instructions are designed for health care professionals.
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