Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K120733
    Device Name
    SIMPLANT GO
    Manufacturer
    MATERIALISE DENTAL NV
    Date Cleared
    2012-07-05

    (118 days)

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

    MATERIALISE DENTAL NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Materialise Dental's SimPlant Go software is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is intended for use as a pre-operative software program for simulating /evaluating dental implant placement and surgical treatment options.
    Device Description
    SimPlant Go allows the individual patient's CT image to be assessed in a three-dimensional way, to see the anatomical structures without patient contact or surgical insult. It includes features for dental implant treatment simulation. Additional information about the exact geometry of the tooth surfaces can be visualized together with the CT data and periodontic procedures with dental implants can be simulated. The output file is intended to be used in conjunction with diagnostic tools and expert clinical judgment.
    Ask a Question
    K Number
    K113739
    Device Name
    SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM
    Manufacturer
    MATERIALISE DENTAL NV
    Date Cleared
    2012-05-30

    (162 days)

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

    MATERIALISE DENTAL NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SimPlant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function.
    Device Description
    The SimPlant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function. The SimPlant Immediate Smile System enables a predictable dental implant restoration procedure according to case planning done by the clinician. The SimPlant Immediate Smile System enables a provisional prosthesis to be produced prior to and attached in the same session as implant installation. The SimPlant Immediate Smile System includes SimPlant software that provides a method of importing medical imaging information from radiological imaging systems such as a Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) to a computer file that is usable in conjunction with other diagnostic tools and expert clinical judgment. Visual representations of the imaged anatomical structures (e.g. the jaw) are derived, allowing for a three-dimensional assessment of the patient without patient contact. SimPlant enables the clinician to plan the dental implant positions including orientations pre-operatively in a virtual, 3D environment. The case planning can be used to produce patient specific SurgiGuide guides, thus transferring the virtual case planning into physical tools enabling the intra-operative preparation of the implant sites for the installation of implants in accordance to the virtual case planning. The SimPlant Immediate Smile System is based upon knowledge of the locations and orientations of the implants prior to surgery. This knowledge enables the production of a SurgiGuide surgical guide. Aided by the SurgiGuide surgical guide, the implant sites can be prepared and the dental implants placed in the predetermined locations, enabling the immediate installation of the custom-made prefabricated provisional Immediate Smile bridge.
    Ask a Question
    K Number
    K112679
    Device Name
    SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM
    Manufacturer
    MATERIALISE DENTAL NV
    Date Cleared
    2012-02-22

    (161 days)

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

    MATERIALISE DENTAL NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SimPlant Navigator Personalized Dental Care System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment. SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit, which are used intra-operatively to prepare the osteotomy for placement of BIOMET 3i implants pre-operatively determined in the software.
    Device Description
    SimPlant Navigator Personalized Dental Care System provides a method of importing medical imaging information from radiological imaging systems such as Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) to a computer file that is usable in conjunction with other diagnostic tools and expert clinical judgment. Visual representations of the imaged anatomical structures (e.g. the jaw) are derived allowing for a three-dimensional assessment of the patient without patient contact. Dental implant positions including orientations are planned pre-operatively. Computer visualization of the 3D anatomical jaw models, planned implants, planned tooth setup, and numerical measurements assist the surgeon in the creation and approval of a pre-surgical plan. SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit are used intra-operatively to prepare the osteotomy for placement of BIOMET 3i implants pre-operatively determined in the software.
    Ask a Question
    K Number
    K110300
    Device Name
    SIMPLANT 2011
    Manufacturer
    MATERIALISE DENTAL NV
    Date Cleared
    2011-07-01

    (149 days)

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

    MATERIALISE DENTAL NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SimPlant 2011 is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment.
    Device Description
    SimPlant 2011 is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as pro-planning software for dental implant placement and surgical treatment.
    Ask a Question
    K Number
    K081402
    Device Name
    SIMPLANT ORTHO ; VISTADENT 3D
    Manufacturer
    MATERIALISE DENTAL NV
    Date Cleared
    2008-07-18

    (60 days)

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

    MATERIALISE DENTAL NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Materialise Dental's SimPlant Ortho; Vistadent 3D software is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also used as a software system for simulating/evaluating orthodontic treatment i.e. dental bite options.
    Device Description
    Simplant Ortho provides a method of segmenting CT images. This file allows the individual patient's CT image to be assessed in a three-dimensional way, to see the anatomical structures without patient contact or surgical insult. It includes features for cephalometric analysis of the patient and orthodontic treatment simulation. Additional information about the exact geometry of the tooth surfaces can be visualized together with the CT data and orthodontic procedures with TADs (temporary anchorage devices) can be simulated. Osteotomies and distractions can be visualized to simulate the desired relation of both jaws and the result on the soft tissue profile of the patient can be visualized. The output file is intended to be used in conjunction with diagnostic tools and expert clinical judgment. SimPlant Ortho; Vistadent 3D is software for simulating/evaluating orthodontic treatment (i.e. dental bite options) programmed in C++ language and running on the Windows operating system.
    Ask a Question

    Page 1 of 1