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510(k) Data Aggregation

    K Number
    K202256
    Device Name
    3Shape Implant Studio
    Manufacturer
    3Shape Medical A/S
    Date Cleared
    2020-09-09

    (30 days)

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

    3Shape Medical A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3Shape Implant Studio is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation of patient anatomy and dental implant placement. Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.
    Device Description
    3Shape Implant Studio® is a stand-alone software device used to pre-operatively plan the placement of a dental implant based on the visualization of a patient's CT image, optionally aligned to an optical 3D surface scan. A virtual surgical quide can be designed and then exported to an external system for manufacturing. The device has no patient contact being a software only device.
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    K Number
    K152078
    Device Name
    Implant Studio 2015
    Manufacturer
    3Shape Medical A/S
    Date Cleared
    2015-12-04

    (130 days)

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

    3Shape Medical A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Implant Studio™ is indicated for use as a medical front-end software that can be used by medically trained professionals for the purpose of visualizing gray value images. It is intended for use as a pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
    Device Description
    Implant Studio™ is a software only device used to pre-operatively plan the placement of a dental implant and to visualize a patient's CT image, optionally aligned to an optical 3D surface data. Virtual crown(s) can be used to guide the planning under the final prosthetic aspect. The surgical quide data can be designed then exported to an external system for manufacturing. The device has no patient contact.
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    K Number
    K141570
    Device Name
    IMPLANT STUDIO
    Manufacturer
    3SHAPE MEDICAL A/S
    Date Cleared
    2014-10-31

    (141 days)

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

    3SHAPE MEDICAL A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Implant Studio™ is indicated for use as a medical front-end software that can be used by medically trained professionals for the purpose of visualizing gray value images. It is intended for use as a pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
    Device Description
    Implant Studio™ is a software only device used to pre-operatively plan the placement of a dental implant and to visualize a patient's CT image, optionally aligned to an optical 3D surface data. Virtual crown(s) can be used to quide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing. The device has no patient contact.
    Ask a Question

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