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510(k) Data Aggregation

    K Number
    K071485
    Device Name
    TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888
    Date Cleared
    2007-08-28

    (90 days)

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

    TPC ADVANCED TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AdvanceCAM intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in decribing the dental procedure being performed as well as showing the results
    Device Description
    AdvanceCAM Intra Oral Camera System and Accessories
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    K Number
    K051547
    Device Name
    POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30
    Date Cleared
    2005-07-14

    (31 days)

    Product Code
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TPC ADVANCED TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PowerMAX Ultrasonic Scaler is intended for use during dental cleanings and periodontal therapy to remove calculus deposits form teeth by application of an ultrasonic vibrating scaler tip to the teeth.
    Device Description
    Not Found
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    K Number
    K983029
    Device Name
    POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001
    Date Cleared
    1999-01-29

    (151 days)

    Product Code
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TPC ADVANCED TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Power Plus Scaler is intended for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
    Device Description
    The Power Plus Scaler is available in two models: a 25 kHz power output and a 30 kHz power output. The Power Plus comes equipped with a turbo mode and can be operated in scaling or perio mode functions. The Power Plus Scaler is equipped with water adjustment and power adjustment. The unit is operated by a footswitch and comes complete with a handpiece. The handpiece is compatible with Cavitron® and TPC Advance Technology tips.
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