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510(k) Data Aggregation

    K Number
    K112585
    Device Name
    TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM
    Manufacturer
    ADIN DENTAL IMPLANTS SYSTEM LTD
    Date Cleared
    2012-05-24

    (261 days)

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

    ADIN DENTAL IMPLANTS SYSTEM LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Touareg CloseFit™ Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. Touareg CloseFit™ Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading
    Device Description
    Touareg CloseFit™ Dental Implants are threaded, root-form dental implants intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The Touareg CloseFit™ Dental Implants are similar in design to the Touareg Dental Implant cleared under Adin Dental Implant System. K081751. The predicate internal connection was changed to internal hex (hexagonal) Morse tapered connection. In addition, dental implant name was changed from Touareg Dental Implants to the Touareg CloseFit™ Dental Implants to extend Touareg Implants family's product line, and surface treatment name was changed to OsseoFix™ due to marketing reasons only. Also, lengths and diameters were added - implants are now provided in diameter of 4.3mm, and lengths of 15.0 mm and 18.0 mm.
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    K Number
    K081751
    Device Name
    ADIN DENTAL IMPLANTS SYSTEM
    Manufacturer
    ADIN DENTAL IMPLANTS SYSTEM LTD
    Date Cleared
    2008-12-19

    (183 days)

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

    ADIN DENTAL IMPLANTS SYSTEM LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading
    Device Description
    Not Found
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