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510(k) Data Aggregation

    K Number
    K042931
    Device Name
    TUF LINK SILICONE RELINER
    Manufacturer
    DENTATUS USA, LTD.
    Date Cleared
    2004-12-08

    (47 days)

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

    DENTATUS USA, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TUF LiNK Silicone Reliner is applied to acrylic dentures for the purpose of providing a soft tissue-bearing surface to the denture for patient comfort.
    Device Description
    Not Found
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    K Number
    K031793
    Device Name
    DENTATUS OSCIOMAT
    Manufacturer
    DENTATUS USA, LTD.
    Date Cleared
    2003-11-13

    (156 days)

    Product Code
    DZH
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTATUS USA, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dentatus Osciomat is intended for use in preparing bone in conjunction with dental and craniofacial surgical procedures.
    Device Description
    Not Found
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    K Number
    K980620
    Device Name
    DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM
    Manufacturer
    DENTATUS USA, LTD.
    Date Cleared
    1998-05-15

    (86 days)

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

    DENTATUS USA, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to be placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. Examples: Support andhors for temporary restorations during the healing and osseointegration process of permanent implants. Immediate loading temporary abutments for repairing failing tooth and implant suported restorations. Transitional supports for immediate replacement of missing teeth. Provide assistance in case planning, implant position alignments, and interim anchor foundations.
    Device Description
    The Dentatus Mini Transitional Implants (MTTM) are titanium or titanium-alloy threaded posts, 1.8 mm to 2.5 mm in diameter and from 14 to 22 mm. in length. There are variations; they are threaded at the bottom-self-tapping, and the "head" is of slightly varying shapes.
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    K Number
    K961704
    Device Name
    MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM
    Manufacturer
    DENTATUS USA, LTD.
    Date Cleared
    1996-07-26

    (85 days)

    Product Code
    ELS
    Regulation Number
    872.3890
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTATUS USA, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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