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510(k) Data Aggregation

    K Number
    K202855
    Device Name
    Orthodontic Facemask
    Manufacturer
    ITA.O Italian Orthodontic System S.r.l.
    Date Cleared
    2021-06-21

    (266 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Product Code :

    DZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthodontic Facemask is used as a treatment option for Class III malocclusions.
    Device Description
    Not Found
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    K Number
    K162543
    Device Name
    Reverse Pull Adjustable Facemask
    Manufacturer
    SAWBROS INDUSTRIES PVT.LTD.
    Date Cleared
    2017-08-28

    (350 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Product Code :

    DZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use as a treatment option for Class III malocclusion.
    Device Description
    The Reverse Pull Adjustable Facemask is an extra oral device placed on the face of a patient. The subject device is provided assembled; packaged in a plastic heat sealed bag placed in a nylon pouch, to safeguard the integrity of the packaging. The device is provided non(sterile. No prior skin preparation is required to use the device. The skin contacting surfaces may require light cleaning with water between uses, depending on the patient's personal hygiene. The subject device consists of a vertical main frame, made of 304(grade stainless steel, having adjustable supports for the patient's forehead and chin. The two supports are lined with Ethylene( Vinyl Acetate (EVA) plastic foam for patient comfort. Moreover, the forehead support has two vents to allow airflow to skin in contact with the support. Two additional EVA pads for forehead and chin supports are included for patient comfort and hygiene. An elastic capstan crossbar made of 304 grade stainless steel, with an allen screw is present on the vertical main frame between the forehead and chin support. The crossbar is utilized by the Orthodontic practitioner as a means of anchorage support for attaching elastics to intraoral appliances. Elastics or the intraoral appliances are not provided with this device.
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    K Number
    K111169
    Device Name
    PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF
    Manufacturer
    KWANG MYUNG DAICOM INC
    Date Cleared
    2011-10-03

    (160 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Product Code :

    DZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Protraction Face Mask and Reverse Pull Face Mask are used as a treatment option for Class III malocclusions.
    Device Description
    Not Found
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    K Number
    K103019
    Device Name
    KJ MASK
    Manufacturer
    KJ MEDITECH CO., LTD
    Date Cleared
    2011-06-09

    (240 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Product Code :

    DZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KJ Mask is used as a treatment option for Class III malocclusions.
    Device Description
    KJ Mask (KM 102-S, KM 201-L) is a device made of materials such as aluminum alloy, stainless steel and plastic intended to be placed on face for the purpose of orthodontics. The device is constructed of four parts, a chip cup, forehead rest, cross bar and main frame. It is intended to exert orthopedic or orthodontic forces of the maxillary arch in order to effect a change in the position of the maxilla in relation to the mandible and other facial structures.
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    K Number
    K052553
    Device Name
    NITOM LOCKING FACEBOW
    Manufacturer
    RUSSELL SAMUELS ORTHODONTIC DESIGN
    Date Cleared
    2005-12-22

    (97 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Product Code :

    DZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitom Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. It has two catches or locks on the inner bow to prevent it accidentally coming out at night.
    Device Description
    The Nitom Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. The Nitom Facebow has two catches or locks on the inner bow to prevent it accidentally coming out at night. It is attached to extra oral traction tubes of the patients fixed orthodontic appliance on the upper first molars. It is usually worn by the patient in the evening and at night. It improves the anchorage of the upper back teeth. It is made of stainless steel.
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    K Number
    K051751
    Device Name
    EQUA-PULL SAFETY RELEASE MODULE
    Manufacturer
    ORTHO TECHNOLOGY
    Date Cleared
    2005-07-22

    (23 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Product Code :

    DZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety. The devices are for Orthodontic Use Only, on the order of an Orthodontist.
    Device Description
    Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety.
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    K Number
    K041718
    Device Name
    KELES FACEMASK
    Manufacturer
    GREAT LAKES ORTHODONTICS, LTD.
    Date Cleared
    2004-10-15

    (113 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Product Code :

    DZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keles protraction face mask is used in the treatment of patients with Class III The Keles profitaction facc mask is used in the neationed maxilla. The facemask is especially useful in patients with an anterior bite tendency or condition.
    Device Description
    The Keles Facemask is an orthodontic headgear device. All components have been used in legally marketed devices or have been found to be safe for dental use.
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    K Number
    K032392
    Device Name
    MORALES PROTRACTION FACEMASK
    Manufacturer
    ORTOSIM, S.A. DE C.V.
    Date Cleared
    2003-10-22

    (79 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Product Code :

    DZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.
    Device Description
    Not Found
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    K Number
    K000358
    Device Name
    MULTI ADJUSTABLE FACE MASK
    Manufacturer
    ORTHO TECHNOLOGY
    Date Cleared
    2000-06-09

    (126 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Product Code :

    DZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993224
    Device Name
    T-GEAR, MODEL TG/400-700
    Manufacturer
    DONTECH PRODUCTS B.V.
    Date Cleared
    2000-02-11

    (137 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Product Code :

    DZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Gear is a cervical headgear traction appliance that delivers constant forces on the dentition of an orthodontic patient. This device is used to treat 'Overbite' and 'Overjet'.
    Device Description
    The T-Gear is a cervical headgear traction appliance that delivers constant forces on the dentition of an orthodontic patient.
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