Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K240143
    Device Name
    JDZygoma dental implants
    Manufacturer
    Date Cleared
    2024-10-11

    (267 days)

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

    JDentalCare Srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    JDZygoma Dental implant is a JDentalCare implant system. JDZygoma Dental implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxilla, in order to restore patient esthetics and chewing function. The JDZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    JDZygoma dental implants are implantable devices produced in commercially pure titanium, intended to be integrated in the Zygomatic bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function. The JDZygoma implant bodies are single use, gamma sterilized devices that shall be used by qualified medical personnel. The abutments are supplied non sterile and must be sterilized prior to use. The JDZYGOMA DENTAL IMPLANTS includes 2 lines of devices with different body diameters of implants (3.9 mm and 4.3 mm) with different implant lengths: - Diameter(mm) 3.9 Lengths (mm): 30 / 35 / 37.5 / 40 / 42.5 / 45 / 47.5 / 50 / 52.5 / 55 / 57.5 ● - Diameter(mm) 4.3 Lengths (mm): 30 / 35 / 37.5 / 40 / 42.5 / 45 / 47.5 / 50 / 52.5 / 55 / 57.5 . The surfaces JDZYGOMA DENTAL IMPLANTS, both 3.9 mm and 4.3 mm of diameter, is machined in the distal part of the fixture while the apical part, the threaded part, is characterized by a surface that is a SLA surface obtained through a sandblasting process followed by acid etching. Machined surface has been analyzed form a morphological point of view using scanning electron microscope (SEM) with different level of magnification (100x, 500x, 1000x and 250x) and also performing a 3D analysis, that allow to define roughness profile with an average height of selected area (Sa) equal to 0.64 um, with a Root mean square gradient (Sdq) of 1.06 and a developed interfacial area ratio (Sdr) of 47.64%. The abutments are made of titanium grade 5 and have the following angulations: - . 45° 52.5° and 60° The connection implant / abutment is done through an internal hexagon. The conical abutments surface is completely treated with anodic oxidation resulting in perception of yellow color. The anodization process is performed by immersing the anodization solution and by providing an electrical voltage for a time necessary to activate the process with the material (titanium grade 5) and then performing washing process and drying the devices. The result of this process has been evaluated from a morphological point of view using scanning electron microscope (SEM), measuring the roughness parameters and performing qualitative analysis of the chemical composition of the abutments surface with X-Ray detector considering and comparing both a non anodized abutments and the same anodized abutments in their finished forms. These evaluations show a relatively uniform surface with characteristic textures of typical machined titanium, clean and free from significant residues or contaminants, with a morphology of the surface before and after anodization that doesn't show appreciable differences also for roughness and X-ray analysis identify a presence of only of Ti, Al, V, O, as expected.
    Ask a Question

    Ask a specific question about this device

    K Number
    K233896
    Device Name
    JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus
    Manufacturer
    Date Cleared
    2024-08-16

    (249 days)

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

    JDentalCare Srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible. .DentalCare Dental Implant System 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 Dental Implant System is intended for immediate function on single tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. When a one-stage surgical approach is applied, the immediately loaded when good primary stability is achieved and the functional load is appropriate. Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. JDental Care 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
    Device Description
    JDentalCare S.r.l. manufactures Dental Implant Systems made by Endosseous Dental Implants, Abutment and related accessories, in order to support dentist in performing Dental Implant Surgery. In order to grant Dentists with a wide range of prosthesis solution, the JDentalCare® Dental Implant System are proposed with different trade name within families lines JDEvolution® plus, JDIcon®, JDIcon® plus, characterized mainly by same mechanical and surface treatment solution and different measure of the hexagon in the connection system. All families have the internal hexagon connection. JDentalCare® Dental Implant System is a two-piece implant made of commercially pure titanium. The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis. The connection is done through an internal hexagon: abutment and other accessories are exclusively designed for JDentalCare® Dental Implant System.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1