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510(k) Data Aggregation

    K Number
    K100785
    Device Name
    BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2010-12-03

    (259 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    BONART CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ART-IM1 Implantor is an implant machine system. It is primarily used by dental professionals in doing oral implant surgery or implantology such as drilling, reaming, cutting, etc. This system is also used for fixing previous broken or failed implant procedure.
    Device Description
    BonartART-IM1 Implantor System & Accessories
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    K Number
    K082971
    Device Name
    BONART ART-L5 LED CORDLESS CURING LIGHT
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2008-11-13

    (38 days)

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

    BONART CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ART-L5 LED Cordless Curing Light System is used in light polymerization of dental composite and curing dental restorative thru source of illuminations.
    Device Description
    Not Found
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    K Number
    K081550
    Device Name
    BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2008-08-28

    (86 days)

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

    BONART CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ART-P31! Pro Multi-function piezoelectric Ultrasonic system is intended for use by medical professionals during denral cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel t p dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, B53 etc.) and is designed to generate a vibrating frequency of 29Khz. ART-M311 Pro Multi-function-Magnet Ultrasonic System is intended for use by medical professionals during demal cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Insert comes in various shapes (ART P-10, ART SLI-P100, ART IF50 etc.) and is designed to generate a vibrating frequency of 24.5KHz. ±5%.
    Device Description
    Not Found
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    K Number
    K080761
    Device Name
    BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2008-08-25

    (160 days)

    Product Code
    DZI
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    BONART CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARTeotomy Ultrasonic surgery system (OP1) uses piezoelectric ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal soft tissue trauma. The system is supplied with sharp, smoothing and blunt insert tips for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Piezo tips come in various shapes and forms (BS-OTI, BS-OT3, BS-OT5 etc.) and are designed to generate a vibrating frequency of 26-32 kHz The ARTeotomy Ultrasonic Surgery System (OM1) uses magnetostrictive ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue. The system is supplied with sharp, smoothing and blunt insert for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Inserts come in various shapes and forms (ART-AS, ART-LH, ART-LV etc.) and are designed to generate a vibrating frequency of 24.5 kHz.
    Device Description
    Not Found
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    K Number
    K071981
    Device Name
    BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2007-10-26

    (100 days)

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

    BONART CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ART-P6 Piczo Electric Ultrasonic Scaler is intended for use by medical professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, BS3 etc.) and is designed to generate a vibrating frequency of 29Khz,
    Device Description
    BONART ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
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    K Number
    K062289
    Device Name
    BONART ART-L3 LED CURING LIGHT
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2007-01-03

    (149 days)

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

    BONART CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Source of illumination for curing dental is restorative materials.
    Device Description
    BONART ART-L3 LED CURING LIGHT
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    K Number
    K061448
    Device Name
    BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2006-08-17

    (87 days)

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

    BONART CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BONART's ART-P3II & ART-P4 Piezo Ultrasonic Scaler are intended for use by medical professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Tip". Tips come in various shapes (BS1, BS2, BS3 etc.) and are designed to generate a vibrating frequency of 29Khz.
    Device Description
    BONART ART-P3II PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS) BONART ART-P4 PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS)
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    K Number
    K052028
    Device Name
    BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2005-10-28

    (93 days)

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

    BONART CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K023721
    Device Name
    BONART ART-L2 LIGHT CURING UNIT
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2003-01-10

    (66 days)

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

    BONART CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ART-L2 uses the optical characteristics of the light to generate radial spectrum of the bulb to go through the optical lens and produce appropriate radial light power density via optical fiber and projected on the mixed resin of dentistry filling substances special filling material to achieve tooth filling effect.
    Device Description
    ART-L2 LIGHT CURING UNIT
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    K Number
    K000510
    Device Name
    ART-M1, MODEL M1-1-ART-A1
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2000-05-15

    (90 days)

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

    BONART CO. LTD.

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

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