Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K150747
    Device Name
    EzDent-i /E2/Prora View
    Manufacturer
    LK Consulting Group USA, Inc.
    Date Cleared
    2015-04-02

    (10 days)

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

    LK Consulting Group USA, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
    Device Description
    EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment. EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616) but the EzDent-i itself does not view, transfer or process 3D radiographs. EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor images by interfacing with X-ray capture software. EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are; - · Easy and convenient data search function for patient information and clinical images - · Various image viewing format for 2D dental images - · Various image processing functions including adjustment of brightness and contrast for images - · Measurement function of length and angle for 2D images - · Dental implant simulation for treatment planning and effective patient consultation - · Crown simulation for more effective patient consultation - · Print function supporting various viewing output format
    Ask a Question
    K Number
    K130694
    Device Name
    JR IMPLANT SYSTEM
    Manufacturer
    LK Consulting Group USA, Inc.
    Date Cleared
    2014-06-19

    (462 days)

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

    LK Consulting Group USA, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JR Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The JR Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
    Device Description
    The JR Implant system is made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the implant has been treated with R.B.M (Resorbable Blast Media). The fixtures are offered in the following length and diameter. There are five different types of abutments offered and they are provided straight only.
    Ask a Question
    K Number
    K132144
    Device Name
    KERATOR
    Manufacturer
    LK Consulting Group USA, Inc.
    Date Cleared
    2014-03-21

    (253 days)

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

    LK Consulting Group USA, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kerator fixture is intended for use in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations. The Kerator abutments are intended use with overdentures or partial dentures. Kerator AO type is compatible with Kerator fixture and the following types are compatible with the fixtures made by other manufacturers as indicated below.
    Device Description
    The Kerator is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. There are one fixture model and three abutment models in the Kerator. Among three abutment model is compatible with the Kerator fixture, and the other two abutment models are compatible with the fixtures made by other manufacturers. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the fixture has been treated with R.B.M (Resorbable Blast Media) and the head part of the abutment has TiN coating over it. The Kerator abutment is placed into the dental implant to provide support for a prosthetic restoration.
    Ask a Question

    Page 1 of 1