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510(k) Data Aggregation

    K Number
    K192348
    Device Name
    SICAT Implant V2.0
    Manufacturer
    SICAT GmbH & Co. KG
    Date Cleared
    2019-12-04

    (97 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SICAT GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SICAT Implant is a software application of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. SICAT Implant is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data can be exported from SICAT Implanning data includes in particular the positions and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical guides for dental implants.
    Device Description
    SICAT Implant V2.0 is a pure software device. SICAT Implant V2.0 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. SICAT Implant V2.0 is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. SICAT Implant V2.0 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerves) within the visualized 3D volume. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures. The dental professionals' planning data can be exported from SICAT Implant. This planning data includes in particular the positions, orientations and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical quides for dental implants.
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    K Number
    K180262
    Device Name
    SICAT Endo
    Manufacturer
    SICAT GmbH & Co. KG
    Date Cleared
    2018-03-12

    (41 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SICAT GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Aiding diagnosis in the oral-maxillofacial region - Aiding comparisons of different treatment options - · Aiding endodontic treatment planning - · Aiding treatment planning for endodontic surgical guides
    Device Description
    SICAT Endo is a pure software device. SICAT Endo is a software tool intended for viewing and analyzing medical information: - medical 3D volume data such as volumetric X-ray data from Cone Beam CT (CBCT) and CT scanners, and - . intraoral images, and - . 3D optical surface data like optical impression data from optical scanners, and SICAT Endo provides tools for analyzing the root canal and to mark it visually. It allows to define a drill canal and ordering of a corresponding surgical quide with a drill sleeve.
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    K Number
    K153291
    Device Name
    SICAT OPTISLEEP
    Manufacturer
    SICAT GMBH & CO. KG
    Date Cleared
    2016-03-31

    (139 days)

    Product Code
    LRK, LQZ
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SICAT GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In adult population - · To reduce or alleviate snoring - To reduce or alleviate mild to moderate obstructive sleep apnea (OSA)
    Device Description
    SICAT OPTISLEEP is a pure hardware device. It is an oral appliance and will be manufactured by the SICAT dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients. SICAT OPTISLEEP is fitted on the maxillary and mandibular arch covering all teeth. It consists of two main parts (upper and lower arch each) that are interconnected by exchangeable connectors. This device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep by reducing mechanical obstructions of the airway. Further this results in lower tendency to snore. The device has an adjustment mechanism, achieved by exchangeable connectors of different length, to adjust the mandibular advancement to be set by the dentist or physician at the time of fitting. The SICAT OPTISLEEP will be worn only during the sleep. The device will be used before replacement up to two years.
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    K Number
    K143655
    Device Name
    SICAT OPTIMOTION
    Manufacturer
    SICAT GMBH & CO. KG
    Date Cleared
    2015-10-02

    (283 days)

    Product Code
    MQC, MOC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SICAT GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Protection of teeth and restorations from injury due to bruxism. - Temporary relief of Temporal Mandibular Disorder (TMD) and bruxism by reducing muscle tension. - Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
    Device Description
    Not Found
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    K Number
    K133320
    Device Name
    SICAT FUNCTION
    Manufacturer
    SICAT GMBH & CO. KG
    Date Cleared
    2014-02-25

    (120 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SICAT GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. It is also used as a software system to aid qualified dental professionals with the evaluation of dental treatment options. The dental professionals' planning data may be exported from SICAT Function and used as input data for CAD or Rapid Prototyping Systems.
    Device Description
    SICAT Function is a pure software device. SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or Cone Beam - CT scanners. This information can be complemented by the imaging information from optical impression systems and jaw tracking devices. The additional information about the exact geometry of the tooth surfaces and the mandibular movement can be visualized together with the radiological data. SICAT Function is also used as a software system to aid qualified dental professionals with the evaluation and planning of dental treatment options. The dental professionals' treatment planning information may be exported from SICAT Function to be used as input data for the manufacturing of therapeutic devices such as oral appliances.
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    K Number
    K103723
    Device Name
    SICAT IMPLANT V1.2
    Manufacturer
    SICAT GMBH & CO. KG
    Date Cleared
    2011-05-20

    (150 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SICAT GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SICAT Implant V 1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. The SICAT Implant V 1.2 is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data may be exported from SICAT Implant V 1.2 and used as input data for CAD or Rapid Prototyping Systems.
    Device Description
    SICAT Implant V1.2 is a pure software device. SICAT Implant V1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. SICAT Implant V1.2 is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. SICAT Implant V1.2 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerve canals) within the visualized 3D volume. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures. The dental professionals' planning data may be exported from SICAT Implant V1.2 and used as input data for CAD or Rapid Prototyping Systems.
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    K Number
    K093090
    Device Name
    GALILEOS IMPLANT, VERSION 1.7
    Manufacturer
    SICAT GMBH & CO. KG
    Date Cleared
    2009-12-17

    (77 days)

    Product Code
    LLZ, REG
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SICAT GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GALILEOS Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD (Computer-Aided Design) or Rapid Prototyping , Systems.
    Device Description
    GALILEOS Implant V1.7 is a pure software device. GALILEOS Implant V 1.7 is a planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. GALILEOS Implant V1.7 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerve canals) within the visualized 3D volume. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of Implants to be placed in the patient's mandible/maxilla together with the related surgical procedures. The dental professionals' planning data may be exported from GALILEOS Implant V1.7 and used as input data for CAD (Computer-Aided Design) or Rapid Prototyping Systems.
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    K Number
    K090119
    Device Name
    SICAT IMPLANT
    Manufacturer
    SICAT GMBH & CO. KG
    Date Cleared
    2009-02-05

    (15 days)

    Product Code
    LLZ, 892
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SICAT GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SICAT Implant is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. SICAT Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data may be exported from SICAT Implant and used as input data for CAD or Rapid Prototyping Systems.
    Device Description
    SICAT Implant is a pure software device. SICAT Implant is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. SICAT Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. SICAT Implant allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerve canals) within the visualized 3D volume. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures. The dental professionals' planning data may be exported from SICAT Implant and used as input data for CAD or Rapid Prototyping Systems.
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    K Number
    K061472
    Device Name
    GALILEOS IMPLANT, V 1.0
    Manufacturer
    SICAT GMBH & CO. KG
    Date Cleared
    2006-06-09

    (10 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SICAT GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GALILEOS Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD or Rapid Prototyping Systems.
    Device Description
    GALILEOS Implant is a pure software device. GALILEOS Implant is an Add-On to the 3D-viewing software Sirona GALAXIS. GALILEOS Implant adds features for pre-operative simulation / evaluation of dental implant placement and surgical treatment options. GALILEOS Implant allows to name, position, move, rotate, resize and visualize generic dental implants and other planning objects (i.e. nerve canals) within the 3D volume data visualized by Sirona GALAXIS. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures.
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