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510(k) Data Aggregation

    K Number
    K170822
    Device Name
    Electronic Caries Detector
    Manufacturer
    Ortek Therapeutics, Inc.
    Date Cleared
    2017-09-11

    (175 days)

    Product Code
    NBL, LFC
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ortek Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electronic Caries Detector is for use by dental professionals as an aid in the diagnosis and monitoring of dental caries.
    Device Description
    The ECD is a portable instrument that provides an electrical current source, a meter with a digital read-out between 00 and 100, and indicator and reference electrodes to aid in the detection and monitoring of non-cavitated and cavitated caries lesions in teeth. The ECD indicator electrode is comprised of a replaceable, single-use, stainless steel probe tip. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures electrical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The ECD indicator electrode is paired with a reference electrode to complete the necessary electrical circuit. The reference electrode is a stainless steel lip hook that rests on the patient's lower lip. The device is powered by a 9 volt alkaline battery, regulated down to 5 volts. The unit has a 2 ½ digit LCD display, two timer circuits, and a beeper. The first timing circuit is triggered upon circuit completion. The beeper sounds for 3 seconds, the probe is then removed, and the second timer holds the display for 5 seconds. Then the display returns to zero, ready for the next measurement.
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    K Number
    K003482
    Device Name
    PROCLUDE-SENSITIVE
    Manufacturer
    ORTEK THERAPEUTICS, INC.
    Date Cleared
    2001-02-01

    (84 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTEK THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002989
    Device Name
    PROCLUDE
    Manufacturer
    ORTEK THERAPEUTICS, INC.
    Date Cleared
    2000-12-14

    (80 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTEK THERAPEUTICS, INC.

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

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