(401 days)
The IMMEDIATELOAD Dental Implant System is intended to be surgically inserted into the jawbone for support and retention of dental prosthesis such as artificial teeth, crowns, bridges and overdenture to restore the aesthetics of the patient and the mastication function.
The IMMEDIATELOAD dental implant system is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The UNIVERSE implants can be used for surgery in two stages or in single stage.
The POWER and SOLUTION implants can be used for surgery in single stage.
All IMMEDIATELOAD dental implants have a double external thread that looks flattened from the proximal area to the distal area. There are three types of implants: UNIVERSE (conical biphasic), POWER (conical monophasic), and SOLUTION (cylindrical monophasic), available in different diameters and length combinations. All the implants are made of Titanium Grade 4. They are provided sterile and are ready to be implanted.
For each measure, the connection between the biphasic implant and the relative prosthetic component is secured by a locking taper connection and a preformed hexagon and by a retained screw.
The abutments are prosthetic accessories made of Titanium Grade 5; they are used to engage, form and create dentures. In particular, the abutment is designed to be applied on the biphasic implant during the surgical reopening, after osseointegration. The straight abutment IMMEDIATE has a straight axis compared to implant's axis. It has a transmucosal collar height ranging from 1 mm to 4 mm.
The inclined abutment IMMEDIATE has axis inclined of 15° compared to the implant's axis. It has a transmucosal collar height ranging from 1 mm to 3 mm. These abutments are fixed to the UNIVERSE implant via a connection screw. The OTK abutment is straight and contains an internal connection screw. It has a transmucosal collar height from 1 mm to 3 mm. The abutments are provided non-sterile and the connection screw for abutments are all provided non-sterile and are intended to be sterilized before use.
This document is a 510(k) summary for a medical device called the "IMMEDIATELOAD Dental Implant System." It describes the device, its intended use, and argues for its substantial equivalence to previously approved predicate devices, primarily based on design, materials, and mechanical performance. It does not describe an AI medical device or a study involving human readers or AI in a clinical setting.
Therefore, I cannot extract the requested information in the format provided because the document does not contain details about:
- Acceptance criteria for an AI device.
- Reported device performance of an AI device.
- Sample sizes for test sets (in the context of AI models).
- Data provenance for AI models.
- Number of experts to establish ground truth for an AI task.
- Adjudication methods for AI performance.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies with AI assistance.
- Standalone performance of an AI algorithm.
- Type of ground truth used for AI models.
- Sample size for a training set of an AI model.
- How ground truth for a training set was established for an AI model.
The "studies" mentioned in this document are non-clinical laboratory tests for a dental implant (e.g., sterilization, biocompatibility, fatigue testing) to demonstrate its physical performance and safety, not for an AI algorithm's diagnostic or predictive capabilities.
§ 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.