Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K130476
    Device Name
    ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
    Manufacturer
    Date Cleared
    2014-01-08

    (317 days)

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

    DENTAL MORELLI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dental Morelli Orthodontic Dental Implant is a threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
    Device Description
    The Orthodontic Miniscrew for Absolute Anchorage is an implantable medical device used as a temporary skeletal anchorage point for orthodontic movements. The mini screw is intended to receive low intensity static clinical loads. Maximum dynamic forces may occur at low frequencies for short periods; which is inadequate to compromise the performance of the product through fatigue. The device is available in different lengths (6, 8, 10, mm), diameter 1.5 mm, and supplied in sealed sterile polyethylene bags.
    Ask a Question

    Ask a specific question about this device

    K Number
    K131197
    Device Name
    EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
    Manufacturer
    Date Cleared
    2013-08-27

    (123 days)

    Product Code
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAL MORELLI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Edgewise and Roth Ceramic Brackets are intended for use in orthodontic treatments. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
    Device Description
    Edgewise and Roth Ceramic Brackets are intended to be bonded to teeth, upon which an orthodontic wire is used to move the teeth to new positions. The Morelli bracket consists of a translucent alumina body. The bracket is uncoated. The Morelli bracket is not self-bonding and requires a primer and adhesive to bond the bracket to the teeth.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1