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510(k) Data Aggregation
K Number
K182198Device 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
872.1800Why 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
K122199Device Name
PREXION3D ECLIPSE
Manufacturer
THE YOSHIDA DENTAL MFG. CO., LTD.
Date Cleared
2013-04-18
(268 days)
Product Code
OAS
Regulation Number
892.1750Why 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
K120948Device Name
PREXION 3D
Manufacturer
THE YOSHIDA DENTAL MFG. CO., LTD.
Date Cleared
2012-12-21
(267 days)
Product Code
OAS
Regulation Number
892.1750Why 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
K120932Device 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
878.4810Why 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
K111231Device Name
PANOURA 18S
Manufacturer
THE YOSHIDA DENTAL MFG. CO., LTD.
Date Cleared
2011-07-13
(72 days)
Product Code
MUH
Regulation Number
872.1800Why 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
K063622Device Name
FINECUBE DENTAL CT
Manufacturer
THE YOSHIDA DENTAL MFG. CO., LTD.
Date Cleared
2007-02-08
(65 days)
Product Code
OAS
Regulation Number
892.1750Why 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
K000577Device 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
872.6640Why 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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