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510(k) Data Aggregation

    K Number
    K182081
    Device Name
    JDentalCare Implant System JDIcon
    Manufacturer
    J Dental Care S.r.l.
    Date Cleared
    2020-06-26

    (694 days)

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

    J Dental Care S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JDentalCare® implant system JDIcon® is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible. JDentalCare® implant system JDIcon® is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. JDentalCare® implant system JDicon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single-stage or two-stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
    Device Description
    JDentalCare® implant system JDIcon® is composed by a fixture and an abutment, joined together by a through screw. The connection is done through an internal hexagon. Abutment and accessories are exclusive for JDentalCare® implant system JDIcon® JDentalCare® implant system JDIcon® is threaded (fully treated or with a collar of 1.5 mm), rootform dental implants, intended to provide a mean for prosthetic attachment in the rehabilitation of partial or total edentulism, in single tooth restorations or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. JDentalCare® implants are made of grade 4 and grade 5 titanium and are tapered. Their surface is treated through sandblasting followed by acid etching treatment. JDIcon® implants may be placed in the oral cavity using either a single stage surgical procedure or a two-stage surgical procedure. If a single procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained. The available dimensions of the JDentalCare® implant system JDIcon®, considering the Fully treated collar version and the machined collar version, are shown in the table below. Note the MACHINED COLLAR referenced is not implanted in bone, making the implantable length of these implants 1.5 mm less than the total implant length listed below.
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