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510(k) Data Aggregation

    K Number
    K060126
    Device Name
    ABSOANCHOR MICROIMPLANT
    Manufacturer
    DENTOS INC.
    Date Cleared
    2006-05-16

    (118 days)

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

    DENTOS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended purpose of the AbsoAnchor microimplant is to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
    Device Description
    The Dentos AbsoAnchor Orthodontic Microimplant is composed of Titanium-6Aluminum-4Vanadium ELI Alloy Grade 5 (ASTM F136) material. It has been designed specifically for orthodontic use and has a button-like head and a bracket-like head with a small hole that accepts ligatures, coil springs, and elastomers. Gingival impingement by these attachments is reduced due to the slanted neck of the implant head. The smaller diameter of AbsoAnchor (1.2mm - 1.8mm) allows its insertion into many areas of the maxilla and mandible and between roots of adjacent teeth. It is classified into 2 implant groups: Taper and Cylinder. It also consists of 8 different head styles: small head, no head, long head, circle head, fixation head, bracket head, bracket head-left handed screw, OMAS mushroom.
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