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510(k) Data Aggregation

    K Number
    K033392
    Device Name
    IMMEDIATE STABILIZING IMPLANT (ISI)
    Manufacturer
    O CO., INC.
    Date Cleared
    2003-12-10

    (48 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    O CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Immediate Stabilizing Implant (ISI) is a one-piece threaded dental implant with the abutment incorporated into the design for a single stage surgical procedure. The implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function. Immediate loading can be obtained if implants are rigidly splinted.
    Device Description
    Self-tapping one-piece CP Titanium threaded dental implant, with a roughened surface treatment. Available in 3.25mm, 4.0mm, and 5.0mm diameter, and in lengths of 8mm 10mm, 12mm, 14mm & 16mm.
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    K Number
    K021978
    Device Name
    PETIT SOPHIA
    Manufacturer
    NISHITOMO CO., INC.
    Date Cleared
    2003-04-08

    (295 days)

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

    NISHITOMO CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For measuring, and recording basal body temperature(BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
    Device Description
    This device is the clinical thermometer with memory the following functions. (1) Alarm clock function for measuring temperature at constant time. (2) Measuring accuracy within +/-0.05°C(between 35.00°C and 38.00°C) +/-0.1°C(between 34.00°C and 35.00°C, 38.00°C and 40.00°C) (3) Displaying the measured temperature precisely, generating the measurement completion signal(buzz) and warning of a measuring error by buzzer, in case happened. (4) Memory capacity of data for 6 menstrual cycles or 210 days. (5) Displaying the measured temperature value in graph. (6) Transferring the stored data to an external instrument.
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    K Number
    K023336
    Device Name
    OCO DENTAL IMPLANT (5.0MM DIAMETER)
    Manufacturer
    O CO., INC.
    Date Cleared
    2002-10-09

    (2 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    O CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "O" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.
    Device Description
    OCO Dental Implant (5.0 mm Diameter)
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    K Number
    K021460
    Device Name
    OCO DENTAL IMPLANT
    Manufacturer
    O CO., INC.
    Date Cleared
    2002-05-22

    (15 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    O CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "0" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw surgically praced in the bone of the or still devices resulting arches providing bart the patient's chewing function.
    Device Description
    OCO Dental Implant (3.25mm diameter)
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    K Number
    K011524
    Device Name
    IMMEDIATE STABILIZING DEVICE (ISD)
    Manufacturer
    O CO., INC.
    Date Cleared
    2002-04-10

    (328 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    O CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010142
    Device Name
    OCO DENTAL IMPLANT
    Manufacturer
    O CO., INC.
    Date Cleared
    2001-02-01

    (15 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    O CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983776
    Device Name
    EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
    Manufacturer
    EVENFLO CO., INC.
    Date Cleared
    1999-04-26

    (182 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    EVENFLO CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are personal use battery/electric powered suction devices used to express milk from the breast of lactating women. These devices are not intended for hospital use.
    Device Description
    The Evenflo Comfort Control Adjustable Speed Breast Pump with Automatic Cycling, and the Evenflo Comfort Control Dual Adjustable Speed Breast Pump with Automatic Cycling are diaphragm type pumps, driven by small DC motors, that create cycling negative pressure. The negative pressure generated by the pump is sufficient to overcome the resistance to the outflow of milk that is created by the muscles, yet gentle enough to prevent tissue damage to the user. The cycling speed and the strength of the negative pressure are controlled by individual rotary controls located on the pump unit. The combination of cycling speed and negative pressure control allow for a range of pressures to be selected. When used as a single collection pump, the maximum negative pressure ranges from 173 mm Hg to 56 mm Hg, and when used in the dual mode, it ranges from 173 mm Hg to 43 mm Hg.
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    K Number
    K973926
    Device Name
    O BUTMENT HS IMPLANT
    Manufacturer
    O CO., INC.
    Date Cleared
    1998-01-05

    (82 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    O CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.
    Device Description
    A cylinder shaped commercially pure titanium dental implant with external threads and a Hydroxylapatite Coating.
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    K Number
    K960727
    Device Name
    EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
    Manufacturer
    EVENFLO CO., INC.
    Date Cleared
    1997-02-14

    (358 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    EVENFLO CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964320
    Device Name
    TONY RISO 25/30 MULTIFUNCTION SCALER
    Manufacturer
    TONY RISO CO., INC.
    Date Cleared
    1997-01-23

    (86 days)

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

    TONY RISO CO., INC.

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