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510(k) Data Aggregation

    K Number
    K063302
    Device Name
    SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
    Date Cleared
    2006-11-15

    (14 days)

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

    SHANGHAI DENTAL INSTRUMENT FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SDIF Dental chairs with operative unit is indicated for use to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is indicated for use in the dental clinic/office environment used by trained dentists and/or dental technicians and assistants
    Device Description
    SDIF dental chairs with operative units provide patient comfort and dentists' air and water supplies for dental instruments and procedures. Water pressure: 200~400Kpa. Air water Supplios for dontar mounts can be powered from ~110/220/230V. The chair is protoure. The system is compatible with instruments from various manufacturers with standard fittings.
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    K Number
    K063110
    Device Name
    CST61 HIGH SPEED TURBINE HANDPIECE
    Date Cleared
    2006-10-26

    (15 days)

    Product Code
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI DENTAL INSTRUMENT FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CST61 High Speed Turbine Handpiece is indicated for use intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth
    Device Description
    CST61 high speed turbine handpiece is an air-powered, hand-held device for use as an operative dental unit accessory at 250KPa with rotation speed of 250,000 RPM in order to perform cutting, shaping, grinding, and polishing functions.
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