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510(k) Data Aggregation
K Number
K133231Device Name
DIGORA OPTIME
Manufacturer
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
Date Cleared
2014-03-20
(150 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIGORA® Optime imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
SOREDEX® DIGORA® Optime system is intended to be used only by dentist and other qualified dental professionals to process x-ray images exposed to the imaging plates from the intraoral complex of the skull.
Device Description
DIGORA® Optime (DXR-60) is a digital radiography system for intra oral imaging plates located in disposable bags. The system may be used with all x-ray equipment which is designed for intra oral radiography. The image is recorded on reusable imaging plate which substitutes for conventional xray film or digital sensor. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by a scanning laser. An optical system collects the emission for photo electronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.
Further image processing, display and achieving are carried out with auxiliary software.
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K Number
K093683Device Name
ORTHOPANTOMOGRAPH OP300
Manufacturer
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
Date Cleared
2010-10-06
(310 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Orthopantomograph® OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray 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 an examined volume for the reconstruction of a 3D view. The device must only be operated and used by dentists and other legally qualified professionals.
Device Description
Orthopantomograph® OP300 is an extraoral source dental x-ray device, which produces conventional digital 2D panoramic, cephalometric and TMJ x-ray images as well as digital x-ray projection images taken during cone beam rotations around a patient's head. The projection images are reconstructed to be viewed in 3D by a 3D viewing software. The name Orthopantomograph® OP300 is used when the device can produce panoramic, TMJ and optionally 3D images. The name Orthoceph® OC300 is used when the cephalometric option for cephalometric x-ray images is added to the device. Furthermore, the device can be equipped with the Volumetric Tomography device (K063773).
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K Number
K092591Device Name
ORTHOPANTOMOGRAPH OP30
Manufacturer
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
Date Cleared
2009-11-20
(88 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Orthopantomograph® OP30 dental panoramic x-ray equipment is indented for dental radiographic examinations by producing digital radiographs of teeth. TM-joints and other oral structures by dentists and other legally qualified professionals.
Device Description
Orthopantomograph® OP30 is an extraoral source dental x-ray equipment, which produces dental panoramic and TMJ images on its digital x-rav image receptor. The technique factor settings are: 66, 70, 73 or 77 kV, 10 mA and max 10 sec.
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K Number
K081925Device Name
SNAPSHOT
Manufacturer
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
Date Cleared
2008-09-02
(57 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Snapshot is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
Device Description
Snapshot is a digital intraoral sensor system that can be connected to a workstation PC via USB connection. The essential function and purpose of the system in a dental clinic is to capture intraoral digital dental x-ray images. The system can be used with general intraoral X-ray units. Snapshot utilizes existing designs and share parts with the predicate Sigma M sensor. The sensor is the same CMOS sensor as that of the predicate device. USB 2.0 High speed connection is used for image transfer to a PC. The basic system consists of Sensor, which is available in two sizes, Workstation software, Sensor holders and hygienic covers.
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K Number
K063837Device Name
SIGMA M
Manufacturer
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
Date Cleared
2007-07-02
(188 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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