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510(k) Data Aggregation

    K Number
    K171872
    Device Name
    P50 Series Dental Operative Unit and Accessories
    Manufacturer
    Pelton & Crane
    Date Cleared
    2018-04-26

    (307 days)

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

    **Pelton **& Crane

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pelton & Crane P50 series Dental Operative Units and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The Pelton & Crane P50 series Dental Operative Units and Accessories are designed for use by a trained professional in the field of dentistry.
    Device Description
    The P50 series Dental Operative Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, patient dental chair, foot control, and a junction box that houses a power supply and air/water regulators. The unit may also include a dental operating light and a monitor. Various handpieces, instruments, and accessories can be added to the P50 series Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them to the P50 series Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments. Water quality is maintained automatically by the preprogramed cleaning functions for the water lines, cuspidor spouts, and instrument hoses including motors and syringes. Instructions are provided for waterline treatment and suction cleaning agents. Water supply is available by either the municipal water supply or a self-contained water bottle.
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    K Number
    K143696
    Device Name
    Spirit
    Manufacturer
    PELTON & CRANE
    Date Cleared
    2015-09-18

    (268 days)

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

    **PELTON **& CRANE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirit Dental Operative Units are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to hand held dental instruments. The Spirit Dental Operative Units are intended for use by professional dental practitioners in providing treatment in a dental operatory.
    Device Description
    The Spirit Dental Operative Units serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, foot control, and a junction box that houses a power supply and air/water regulators. Various Handpieces and accessories can be added to the Spirit Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them into the Sprit Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments.
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    K Number
    K972249
    Device Name
    ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD
    Manufacturer
    PELTON & CRANE CO.
    Date Cleared
    1997-09-12

    (88 days)

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

    **PELTON **& CRANE CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthophos Plus and Orthophos Plus/CD are intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The X-ray source is located outside the mouth. The system provides for panoramic imaging of the entire maxillofacial region as well as transverse slice imaging of the maxillary and mandibular regions.
    Device Description
    The Orthophos Plus contains 23 factory installed programs that allow for comprehensive imaging of the entire maxillofacial region. The Orthophos Plus software programs allow for panoramic radiographs of the teeth, maxillary sinuses, and temporal mandibular joints, as well as transverse panoramic tomographs of the lateral, canine and anterior maxillary and mandibular regions. The device is equipped with various bite block and head positioning accessories. The device is also available with an optional cephalometric attachment (Orthophos Plus/CD).
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    K Number
    K972168
    Device Name
    SIDEXIS DIGITAL RADIOGRAPHY SYSTEM
    Manufacturer
    PELTON & CRANE CO.
    Date Cleared
    1997-09-05

    (88 days)

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

    **PELTON **& CRANE CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SIDEXIS Digital Radiography System consisting of digital sensor, image display is indicated to replace conventional radiographic film when used with extraoral source X-ray systems which are intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
    Device Description
    SIDEXIS Digital Radiography System consisting of digital sensor, image display
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    K Number
    K945117
    Device Name
    DELTA
    Manufacturer
    PELTON & CRANE CO.
    Date Cleared
    1997-02-28

    (864 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    **PELTON **& CRANE CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962071
    Device Name
    SPIRIT S1/S2
    Manufacturer
    PELTON & CRANE CO.
    Date Cleared
    1996-08-06

    (70 days)

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

    **PELTON **& CRANE CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960819
    Device Name
    HELIODENT DS
    Manufacturer
    PELTON & CRANE CO.
    Date Cleared
    1996-03-29

    (29 days)

    Product Code
    EAP
    Regulation Number
    872.1810
    Why did this record match?
    Applicant Name (Manufacturer) :

    **PELTON **& CRANE CO

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

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