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510(k) Data Aggregation

    K Number
    K081653
    Device Name
    MDI MII ONE-PIECE IMPLANT, 2.9MM
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2008-09-19

    (99 days)

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

    IMTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MII Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases.
    Device Description
    The IMTEC MDI MII 2.9mm one-piece implant is a one piece endosseous dental implant that is a combination of implant and abutment sections. The thread lengths are 10mm, 13mm, 15mm, and 18mm. The implant is composed of Titanium alloy. The MDI MII body has a thread design for bone compression and the implant tip is equipped with our patent pending auto advancing cutting threads similar to those found on the IMTEC Endure Implant system. The implant section surface is blasted & etched to facilitate osseointegration. In addition, the implant has micro-threads at the intra-osseous collar to preserve crestal bone. It has a transgingival collar 2mm in height that includes a platform switching groove for soft tissue stability. The Implant has two prosthetic head design options, O-ball and Tapered Abutment design. The O-ball head on the MDI MII is identical to the O-ball head on the IMTEC MDI implant. Both are designed for fixed and removable applications. The abutment portion of the MII implant is coated with Titanium Nitride.
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    K Number
    K081347
    Device Name
    ILUMA VISION
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2008-05-28

    (14 days)

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

    IMTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ILUMA VISION is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologist, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute DICOM 3.0 compliant images, utilizing standard PC hardware. Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. The device is not intended for use with mammography.
    Device Description
    Not Found
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    K Number
    K072660
    Device Name
    ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2007-12-12

    (82 days)

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

    IMTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K053046
    Device Name
    ILUMA ORTHOCAT/DENTALCAT
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2005-11-08

    (11 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMTEC Imaging ILUMA™ OrthoCat™ and DentalCat™ are x-ray devices (cone beam computed tomography) that acquire a single 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support.
    Device Description
    x-ray devices (cone beam computed tomography) that acquire a single 360° rotational sequence
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    K Number
    K043226
    Device Name
    ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2005-01-13

    (52 days)

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

    IMTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To replace missing tooth roots for single tooth, partial tooth, and fully edentulous patients. ENDURE endosseous implants are designed to become an Osseointegrated prosthesis allowing the attachment of a partial or a complete prosthodontic appliance in the mandible or maxilla.
    Device Description
    Not Found
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    K Number
    K042289
    Device Name
    MDI ORTHO
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2004-09-15

    (22 days)

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

    IMTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Implants are intended for single use only.
    Device Description
    Not Found
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    K Number
    K033432
    Device Name
    LEXATITE QUICK ACRYLIC
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2004-01-15

    (79 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LEXATITE QUICK ACRYLIC is intended for use as a self-curing, cold-curing, resin for LEAATTE QUORTAON crowns, bridges, inlays and onlays.
    Device Description
    Not Found
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    K Number
    K031106
    Device Name
    IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2003-08-12

    (126 days)

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

    IMTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDI and MDI PLUS are self-tapping titanium threaded screws indicated for long-term intra-bony applications. Additionally, the MDI may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full partial endentulism, and employing minimally invasive surgical intervention.
    Device Description
    self-tapping titanium threaded screws
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    K Number
    K030243
    Device Name
    ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2003-04-23

    (90 days)

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

    IMTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To replace missing tooth roots for single tooth, partial tooth, and fully edentulous patients. ENDURE endosseous implants are designed to become an Osseointegrated prosthesis allowing the attachment of a partial or a complete prosthodentic appliance in the mandible or maxilla.
    Device Description
    ENDURE endosseous implant
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    K Number
    K024044
    Device Name
    SABER TECH IMPLANTS SYSTEM
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2003-02-21

    (77 days)

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

    IMTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To serve as artificial root structures for single teeth or bridge abutments for bridgework in edentulous sites with adequate bone of sufficient quality to support the implant and function.
    Device Description
    Saber Tech Implants System (GIS) endosseous implant
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