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510(k) Data Aggregation

    K Number
    K163175
    Device Name
    Bel-Cypher Pro
    Date Cleared
    2017-03-20

    (126 days)

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

    Takara Belmont Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bel-Cypher Pro dental panoramic X-ray system is indicated for use as generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the tooth, jaw, and oral structures.
    Device Description
    The Bel-Cypher Pro is a user-friendly, digital panoramic X-ray system that features bitewing imaging capability, as well as diagnostic panoramic and TMJ imaging capabilities. The Bel-Cypher Pro utilizes a high frequency inverter and has a small focal spot to produce crisp, clear images.
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    K Number
    K152100
    Device Name
    Evogue Dental Unit
    Date Cleared
    2016-01-22

    (178 days)

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

    TAKARA BELMONT CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Evogue Dental Unit series are intended for the Dentists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.
    Device Description
    This product is an active therapeutic device intended to administer or exchange energy of electric, air and water for the exclusive use for diagnoses, treatments and relative procedures of dentistry, and its characteristic is not in a potentially hazardous way between such energy and human body, taking account of the nature, the density and site of application of the energy. The product must be operated or handled by the qualified dentists or by dental staffs under the supervision of the dentist. Such dentists or dental staffs should instruct and/or assist the patients to approach to and leave from the product. Patients should not be allowed to operate or handle the product unless he/she is so instructed. The air unit system uses compressed air to drive air motor and air scaler. The new Evogue Dental Unit is air unit system. The function and components used for Evogue Dental Unit are very similar to X-Calibur unit (Belmont Model 2000 Series, K000799). Though the Evogue Dental Unit is typical air system, it does have upgrade ability to use micro motor with external touch pad (MX2 Optima) and integrated type electric scaler (Cavitron). The foot control regulates drive air to the active handpiece to control the rotation speed of turbine and air motor. Also controls the frequency of air scaler. It provides an air signal that activates air coolant and water coolant flow. The foot control is equipped with a wet/dry toggle to turn the water coolant on or off.
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    K Number
    K141293
    Device Name
    PHOT-X IIS MODEL 505
    Date Cleared
    2014-09-03

    (107 days)

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

    TAKARA BELMONT CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PHOT-X IIs Model 505 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.
    Device Description
    PHOT-X IIs Model 505 dental x-ray contains; x-ray generating tubehead, control box and supporting device. Package includes Operator's Manual, Installation Manual and Warranty.
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    K Number
    K110160
    Device Name
    BEL-CYPHER N
    Date Cleared
    2011-02-17

    (29 days)

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

    TAKARA BELMONT CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bel-Cypher N dental panoramic X-ray system is indicated for use as generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the tooth, jaw, and oral structures.
    Device Description
    The Bel-Cypher N dental panoramic 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.
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