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510(k) Data Aggregation

    K Number
    K170732
    Device Name
    Biomate Dental Implant System
    Manufacturer
    Biomate Medical Devices Technology Co., Ltd.
    Date Cleared
    2018-10-26

    (595 days)

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

    Biomate Medical Devices Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.
    Device Description
    The Biomate Dental Implant System consists of Bone Type Implant Plus, Shaping Abutment and Healing Abutment. The Biomate Dental Implant System is made of commercial pure titanium (ASTM F67, Grade 4). Threaded dental implants are with Precision Dimension Laser (PDLTM) surface treatment, while Shaping Abutment and Healing Abutment are with TiN coated surface treatment. The device is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to replace missing teeth.
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    K Number
    K142174
    Device Name
    BIOMATE DENTAL IMPLANT SYSTEM
    Manufacturer
    BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
    Date Cleared
    2015-03-20

    (225 days)

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

    BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.
    Device Description
    The BIOMATE Dental Implant System consists of threaded dental implants in 3.3, 4.1, 4.8, 5.5 mm diameters with 8, 10, 12, 14 mm lengths. The implants are made of commercial pure titanium and coated with the laser-modified Surface. BIOMATE Dental Implant System is comprised of Bone Type Implant, Solid Abutment, Simple Abutment, Angled Abutment, Temporary Abutment, Ball Abutment, Screw, Cover Screw, Healing Abutment. The system is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to be used to replace missing teeth.
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    K Number
    K103061
    Device Name
    BIOMATE STERILE ACUPUNCTURE NEEDLE
    Manufacturer
    BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
    Date Cleared
    2011-06-20

    (245 days)

    Product Code
    MQX, MOX
    Regulation Number
    880.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biomate Sterile Acupuncture Needle, Model: Nano, Nano-PI, Nano-EI is intended to be used to pierce the skin in the practice of acupuncture (by qualified practitioner of acupuncture) as determined by the States.
    Device Description
    Not Found
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