Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    RUSSELL SAMUELS ORTHODONTIC DESIGN

    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.
    Ask a Question

    Page 1 of 1