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510(k) Data Aggregation

    K Number
    K102456
    Device Name
    INTRAORAL BELSENSOR GOLD
    Manufacturer
    TAKARA BELMONT USA, INC.
    Date Cleared
    2011-12-15

    (475 days)

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

    TAKARA BELMONT USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BelSensor GOLD is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The BelSensor GOLD shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The BelSensor GOLD can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.
    Device Description
    The BelSensor GOLD is an indirect converting x-ray detector that converts incident xrays by a scintilator into visable light, which is coupled optically to a light detection imager based on CMOS technology. Incident x-rays are automatically detected to generate digital images for dental intra-oral applications. The BelSensor GOLD supports USB 2.0 connectivity to personal computer.
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    K Number
    K072273
    Device Name
    BELMONT QUOLIS 5000 SERIES DENTAL UNIT
    Manufacturer
    TAKARA BELMONT USA, INC.
    Date Cleared
    2007-12-20

    (127 days)

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

    TAKARA BELMONT USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Unit and Accessories are intended for the Dentists, Hygienists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.
    Device Description
    The Belmont QUOLIS 5000 SERIES DENTAL UNIT is a modification of the existing Belmont Dental Unit, Model 2000 series and Model 6000 series. It is a Dental Operative Unit and Accessories.
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    K Number
    K062529
    Device Name
    BELMAX CM MODEL X168
    Manufacturer
    TAKARA BELMONT USA, INC.
    Date Cleared
    2006-10-05

    (37 days)

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

    TAKARA BELMONT USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BELMAX CM dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
    Device Description
    The BELMAX CM Model X168 X-Ray System is the next generation of the Takara Belmont digital dental X-ray systems. Similar to the prior Takara Belmont ANA-BEL, ANA-BEL CM equipped with the Takara Belmont ADR Plus SSXI, the BELMAX CM Model X168 X-Ray System offers digital imaging with panoramic and cephalometric imaging programs with the same exposure levels (KV/mA). Modifications resulting in the device include a new sized CCD sensor including three rather than two of the same sensor array grids mounted in a removable cartridge rather than bolted in place.
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    K Number
    K041834
    Device Name
    ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM
    Manufacturer
    TAKARA BELMONT USA, INC.
    Date Cleared
    2004-12-03

    (149 days)

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

    TAKARA BELMONT USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADR Plus SSXI Imaging Device for X-ray systems such as X-CALIBER, X-CALIBER CM, ANA-BEL and ANA-BEL CM, a Solid State X-Ray Imaging Device is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended to replace conventional radiographic film for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
    Device Description
    Solid State X-Ray Imaging Device
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    K Number
    K042260
    Device Name
    PHOT-X II, MODEL 303
    Manufacturer
    TAKARA BELMONT USA, INC.
    Date Cleared
    2004-09-07

    (15 days)

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

    TAKARA BELMONT USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PHOT-X II MODEL 303 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor . The design, function and positioning of the x-ray unit is similar to most all other x-ray machines manufactured for this specific purpose over the past thirty years.
    Device Description
    PHOT-X II, MODEL 303 dental x-ray contains; control box, wall mounting, adjustable support arm and x-ray generating tubehead. Package includes Operators Manual, Installation Manual and Warrantee.
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    K Number
    K040748
    Device Name
    ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM
    Manufacturer
    TAKARA BELMONT USA, INC.
    Date Cleared
    2004-06-02

    (71 days)

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

    TAKARA BELMONT USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANA-BEL and ANA-BEL CM dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
    Device Description
    ANA-BEL and ANA-BEL CM, Takara X-Caliber and X-Caliber CM, and PLANMECA 2002 CC Proline Panoramic X-ray all employ X-ray tube with maximum rated peak tube potential of 90 kV.
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