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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

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.

The provided text is a 510(k) Premarket Notification for a dental implant system. It details the device's description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about an AI/ML-enabled medical device.

Therefore, I cannot extract information related to acceptance criteria and the study proving the device meets those criteria for an AI/ML device, as the document describes a physical dental implant system and not an AI/ML product.

The sections regarding acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training sets are all relevant to the evaluation of AI/ML models. Since this document is about a physical medical device (dental implants), these concepts are not applicable in this context.

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