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510(k) Data Aggregation

    K Number
    K062733
    Device Name
    TOMAS PIN SD 6, 8, AND 10 MM
    Manufacturer
    DENTAURUM
    Date Cleared
    2006-11-09

    (57 days)

    Product Code
    OAT, DZF
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAURUM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide a fixed anchorage point for attachment of orthodontic appliances.
    Device Description
    tomas-pin micro screws (orthodontic micro implant) are anchorage elements made of grade 5 titanium (3.7165), according to ASTM (American Society for Testing and Materials). They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The tomaspin is constructed as follows: The screw features hex type slots. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed on the tomas-pin with light cured adhesive should completely/fully enclose the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-on. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head. The thread of the tomas-pin SD is self-drilling. The tomas-pin SD is inserted and screwed into the bone by either manual or mechanical method. The shoulder connection between the thread and soft tissue sleeve serves as a stop to prevent the tomas-pin from sinking into the soft tissue. The soft tissue sleeve between the thread and retention head helps to prevent irritation between the gingiva and the tomas-pin, therefore.
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    K Number
    K062732
    Device Name
    TOMAS PIN 6 MM
    Manufacturer
    DENTAURUM
    Date Cleared
    2006-10-25

    (42 days)

    Product Code
    OAT, DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAURUM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide a fixed anchorage point for attachment of orthodontic appliances.
    Device Description
    Not Found
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    K Number
    K042965
    Device Name
    TOMAS PIN
    Manufacturer
    DENTAURUM, INC.
    Date Cleared
    2005-04-15

    (170 days)

    Product Code
    OAT, DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAURUM, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tomas-pins are temporary, enossal anchorage elements for the treatment of tooth abnormalities in orthodontics and pre-prosthetics. To provide a fixed anchorage point for attachments of orthodontic appliances. Temporary Orthodontic Micro Anchorage
    Device Description
    tomas-pin micro screws (orthodontic micro implant) are precisely manufactired, anchorage elements made or grade 5 thankin (orrroo), according to ASTM (American Society for Testing and Materials). They are insorted into the best as follows: The head of the screw features hex type slots. movements. The tonias pill is constructions or thoughtic elements, such as arches, elastic bands and Reclaigular Wires are misetted to accomments on the tomas-pin with light cured adhesive. The adhesive should blackers. I relevably, the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-pin. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head. The thread of the tomas-pin is self-tapping but not self-drilling, which means that pre-drilling according to the I he tiread of the tomas-pin is ser tapping our it accommodate the tomas-pin. The tomas-pin is inserted and screwed into the bone by either manual or mechanical method. The shoulder connection between the thread and soft tissue sleeve serves as a stop to prevent the tomas-pin I he silouius. Conficenon between the and seeve between the thread and retention head helps to prevent irritation between the borgiva and the tomas-pin, therefore, ensuring optimal hygiene. The tomas-pins are delivered in glass sterile ampoules. The package contains labels that can be inserted into the patient's file for future reference and tracking. The tomas-pins are available in the following sizes: Tomas-pin 08 (Order No. 302-008-00) Length of screw body: 8mm Diameter: 1.2mm Tomas-pin 10 (Order No. 302-010-00) Length of screw body: 10mm Diameter: 1.2mm
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    K Number
    K030644
    Device Name
    CONTEC DUO, CONTEC LC, CONTEC LCR
    Manufacturer
    DENTAURUM
    Date Cleared
    2003-11-21

    (266 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAURUM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ConTec: Duo, ConTec LC, ConTec LCR are adhesive compounds that are used to fix orthodontic appliance to teeth.
    Device Description
    ConTec Duo, ConTec LC, Contec LCR are adhesive compounds
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    K Number
    K032195
    Device Name
    DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT
    Manufacturer
    DENTAURUM
    Date Cleared
    2003-10-07

    (81 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAURUM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dentaurum GlasTec Dental Orthodontic Cement is a dental glass ionomer cement used to cement orthodontic bands to tooth surfaces.
    Device Description
    Dentaurum GlasTec Dental Orthodontic Cement
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    K Number
    K030977
    Device Name
    DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
    Manufacturer
    DENTAURUM
    Date Cleared
    2003-08-25

    (150 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAURUM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dentaurum MIX Two-paste Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (37.4% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.
    Device Description
    Dentaurum MIX Two-paste Bracket Adhesive
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    K Number
    K030980
    Device Name
    DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
    Manufacturer
    DENTAURUM
    Date Cleared
    2003-08-25

    (150 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAURUM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dentaurum NO-MIX One Step Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (37.4% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.
    Device Description
    Not Found
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    K Number
    K030641
    Device Name
    CONTEC LIGHT
    Manufacturer
    DENTAURUM
    Date Cleared
    2003-06-10

    (102 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAURUM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ConTec Light is used to set resinous dental adhesive material by transmission of visible light.
    Device Description
    Not Found
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    K Number
    K011425
    Device Name
    CARMEN
    Manufacturer
    DENTAURUM, INC.
    Date Cleared
    2001-06-05

    (27 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAURUM, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011428
    Device Name
    TRICERAM
    Manufacturer
    DENTAURUM, INC.
    Date Cleared
    2001-06-05

    (27 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAURUM, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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