(249 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.