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510(k) Data Aggregation

    K Number
    K182198
    Device Name
    Panoura X-ERA PF/NF/MF
    Manufacturer
    The Yoshida Dental Mfg. Co., Ltd.
    Date Cleared
    2019-01-31

    (170 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    The Yoshida Dental Mfg. Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for general populations. The device must only be operated and used by dentists and other legally qualified professionals.
    Device Description
    The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is modified from the IMAGEWORKS PANOURA (K122806). The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The device must only be operated and used by dentists and other legally qualified professionals. Panoura X-ERA PF/NF/MF consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. The Console is new software and classified as moderate level concern. 3D Viewer will then perform the image analysis or image edition such as creating cross-section diagram. 3D sensor is not installed for Panoura X-ERA PF. Medium FOV sensor is installed for Panoura X-ERA NF. Large FOV sensor is installed for Panoura X-ERA MF.
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    K Number
    K122199
    Device Name
    PREXION3D ECLIPSE
    Manufacturer
    THE YOSHIDA DENTAL MFG. CO., LTD.
    Date Cleared
    2013-04-18

    (268 days)

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

    THE YOSHIDA DENTAL MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PREXION3D ECLIPSE is intended to produce two-dimensional digital panoramic and cephalometric images, and three-dimensional digital X-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support.
    Device Description
    The PREXION3D ECLIPSE consists of scanner and two software including Console software, and Viewer software used for the Image Analysis System and Data processing. A qualified computer named Console computer is distributed with the PREXION3D ECLIPSE. The PREXION3D ECLIPSE uses the Image Analysis System and the processed data acquired by the scanner to analyze 2D and 3D images, perform image edition, such as creating cross-section views, and output results to a printer or other output device. During scanning, X-rays are generated from the X-ray tube head mounted in the arm of the scanner and the X-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware and the Console software installed on the qualified computer. The detected X-ray absorption data is processed by the Console software and viewer software on each computer to reconstruct images. Scanning is performed using X-ray penetration signals of a patient taken from multiple directions to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial region for the diagnosis of hard tissue The PREXION3D ECLIPSE performs three types of scanning including CT scan generating two (2) or three (3) dimensional images, Panoramic scan generating two (2) dimensional images and Cephalometric radiography generating a plain radiographic image.
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    K Number
    K120948
    Device Name
    PREXION 3D
    Manufacturer
    THE YOSHIDA DENTAL MFG. CO., LTD.
    Date Cleared
    2012-12-21

    (267 days)

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

    THE YOSHIDA DENTAL MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PreXion 3D is intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial regions at the direction of healthcare professionals as diagnostic support.
    Device Description
    The PREXION 3D consists of scanner and two software including Console software, and Viewer software used for the Image Analysis System and Data processing. A qualified computer named Console computer is distributed with the PREXION 3D. The PREXION 3D uses the Image Analysis System and the processed data acquired by the scanner to analyze 2D and 3D images, perform image edition, such as creating cross-section views, and output results to a printer or other output device. During scanning, X-rays are generated from the X-ray tube head mounted in the arm of the scanner and the X-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware and the Console software installed on the qualified computer. The detected X-ray absorption data is processed by the Console software and viewer software on a computer to reconstruct images. Scanning is performed using X-ray penetration signals of a patient taken from multiple directions for the diagnosis of hard tissue including bones and teeth of the jaw and mouth cavity. The PREXION 3D performs two types of scanning including CT scan generating two (2) and three (3) dimensional images and Panoramic scan generating two (2) dimensional images.
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    K Number
    K120932
    Device Name
    OPELASER PRO II AND THE OPELASER LITE II
    Manufacturer
    THE YOSHIDA DENTAL MFG. CO., LTD.
    Date Cleared
    2012-12-07

    (254 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE YOSHIDA DENTAL MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Opelaser Family is CO2 Medical Laser Systems (and the delivery system that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
    Device Description
    These are CO2 Laser devices designed for surgical applications. The maximum power output for the PRO model is 7 watts, and for the LITE model, 5 watts. Type of laser is a CO2 gas laser (class 4); Oscillation system: RF discharge excitation oscillation; Light guiding system: SiO2 hollow fiber or 6 point articulated arm depending on model; Oscillation wavelength: 10.6um.
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    K Number
    K111231
    Device Name
    PANOURA 18S
    Manufacturer
    THE YOSHIDA DENTAL MFG. CO., LTD.
    Date Cleared
    2011-07-13

    (72 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE YOSHIDA DENTAL MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PANOURA 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The device must only be operated and used by dentists and other legally qualified professionals.
    Device Description
    The PANOURA 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The PANOURA 18S is equipped with an X-ray generator and a Sensor unit at Arm unit supported by Column unit and Sliding body unit. While rotating around the patient's teeth and jaw, the PANOURA 18S irradiates X-ray and detects X-ray absorbed data at the Sensor unit multiple times. Detected multiple data are transferred to an image processing unit and the data are superimposed with appropriate shift value according to the X-ray moving speed from the arm rotation to acquire image.
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    K Number
    K063622
    Device Name
    FINECUBE DENTAL CT
    Manufacturer
    THE YOSHIDA DENTAL MFG. CO., LTD.
    Date Cleared
    2007-02-08

    (65 days)

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

    THE YOSHIDA DENTAL MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.
    Device Description
    The FineCube consists of two main elements: (1) The X-Ray generation and acquisition system and (2) the image analysis software. The X-Ray generation/acquisition system creates a cone-shaped x-ray field which is acquired on a flat panel sensor with a resolution of 608 x 616 x 200 um. FineCube is an X-ray imaging device that constructs a three dimensional model from images taken during a rotational X-ray sequence. FineCube is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects
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    K Number
    K000577
    Device Name
    YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA
    Manufacturer
    THE YOSHIDA DENTAL MFG. CO., LTD.
    Date Cleared
    2000-05-05

    (73 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE YOSHIDA DENTAL MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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