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510(k) Data Aggregation

    K Number
    K223507
    Device Name
    CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
    Manufacturer
    Good Doctors Co., Ltd.
    Date Cleared
    2023-08-04

    (255 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Good Doctors Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE)is a hand held LED polymerization light intended to cure dental composites using visible light.
    Device Description
    This unit is a battery type wireless LED curing light. User can adjust light intensity and time by selecting six program modes. Both of Dr's Light PRIME and Dr's Light Choice are characterized by high power intensity, slim head height, large irradiation area (12mm), adjustable intensity power, highly readable color touch screen, 360° twistable head and big capacity of the battery.
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    K Number
    K151274
    Device Name
    Dr's Finder
    Manufacturer
    GOOD DOCTORS CO., LTD.
    Date Cleared
    2016-02-04

    (267 days)

    Product Code
    LQY, LOY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOOD DOCTORS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dr's Finder is intended for detecting the apex of root canal.
    Device Description
    The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 400 Hz, and 10400 Hz. The current between the file and mouth is measured at each of these frequencies, and the readout of the relative proximity to the apex will appear on the meter.
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    K Number
    K093751
    Device Name
    CL-DC20, CL-DC21
    Manufacturer
    GOOD DOCTORS CO., LTD.
    Date Cleared
    2010-02-24

    (79 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOOD DOCTORS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CL-DC20 and CL-DC21 Dental Curing Lights are indicated for the curing of dental composites using visible light.
    Device Description
    Not Found
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    K Number
    K071908
    Device Name
    DOCTOR'S LIGHT LED DENTAL CURING LIGHT
    Manufacturer
    GOOD DOCTORS CO., LTD.
    Date Cleared
    2007-08-23

    (44 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOOD DOCTORS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Curing of dental composites using visible light.
    Device Description
    Doctor's Light LED Dental Curing Light is a hand-held polymerization light intended for use in curing dental composites. This product uses a rechargeable Li-ion Battery for cordless operation.
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