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510(k) Data Aggregation

    K Number
    K151608
    Device Name
    4plus6Line Abutment System
    Manufacturer
    OT MEDICAL GMBH
    Date Cleared
    2016-04-13

    (303 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    OT MEDICAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 4plus6Line Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.
    Device Description
    The abutment is available in several diameters and angulations. The straight and the 17° angled versions are available as compatible with implant bodies in diameters of 3.8mm, 4.1, and 5.0. A 30° angled version is also available for the 4.1mm and 5.0 diameter implant bodies. All abutments are made from titanium grad 5 acc. to ASTM F-136. The abutments are compatible with implant bodies contained in the OT-F" Implant System. The abutment system contains both titanium and POM cylinders as well as healing abutments.
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    K Number
    K151432
    Device Name
    NaturalLine Abutment
    Manufacturer
    OT MEDICAL GMBH
    Date Cleared
    2015-11-05

    (161 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    OT MEDICAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Natural Line abutment is indicated for use in cases where the placement of the implant requires an angled reconstruction for an esthetic result. The abutment can be used to restore crowns for single tooth replacement and bridges for bound situations
    Device Description
    Not Found
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    K Number
    K113113
    Device Name
    ENDOSSEOUS DENTAL IMPLANT
    Manufacturer
    OT MEDICAL GMBH
    Date Cleared
    2012-11-16

    (393 days)

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

    OT MEDICAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OT-F2 Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The OT-F3 Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It is suitable for insertion in completely healed jaw bone (late implantation).
    Device Description
    The OT-F implants are available in the diameters 3.8, 4.1 and 5.0mm. For the diameter 3.8 and 4.1mm there are 5 lengths: 8, 10, 12, 14 and 16 mm, for the diameter 5.0mm only 4 lengths: 8, 10, 12 and 14 mm. The implants are made from titanium grad 4 acc. to ASTM F-67. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All abutments are made from titanium grad 5 acc. to ASTM F-136. The OT-F3 implants are available in the diameters 4.1 and 5.0mm. For each diameter there are 3 lengths: 5, 7 and 9 mm. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All implants are made from titanium grad 5 acc. to ASTM F-136.
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