(228 days)
The EK Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is indicated for delayed loading. Ultra wide versions are indicated for use in the molar region only.
The EK Dental Implants (Ø3.5mm & Ø3.3mm) are made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The EK Dental Implants (Ø3.5mm & Ø3.3mm) are indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
The EK D3.3 and Ultra Wide Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches, providing support to prosthetic devices to restore normal chewing functions. There are two types: SA and NH, both are bone level implants with the exact same internal hex, tapered body, use the same components and prosthetic parts, are manufactured from the same medical grade titanium materials and sterilized via gamma radiation. They only difference is the surface; SA is sand blasted and acid etched and NH is sand blasted and acid etched plus treated with a layer of low crystalline HA and super hydrophilic coating.
The EK D3.3 and Ultra Wide Dental Implants are available in various lengths and diameters; configurations are listed in the table below.
This document describes the premarket notification (510(k)) for the EK D3.3 and Ultra Wide Dental Implants. It focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing a study demonstrating performance against specific acceptance criteria for a new device's efficacy or safety.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria for a new device's performance. Instead, it relies on demonstrating that the new device (EK D3.3 and Ultra Wide Dental Implants) is substantially equivalent to existing, legally marketed predicate devices, thereby leveraging their established safety and effectiveness.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- No new acceptance criteria: The document is a 510(k) summary, which aims to show substantial equivalence. It does not define new, quantitative acceptance criteria for this specific device's novel performance.
- No new performance study: The document explicitly states "No clinical performance report(s) is being submitted." The non-clinical data section describes various tests (Biocompatibility, Sterilization Validation, Shelf Life, Surface Treatment Characterization, Fatigue Testing, MR conditional) where the new device is either identical to the predicate, uses the same processes/materials, or is referenced from existing data. These are comparative tests to support equivalence, not studies proving performance against a set of newly established acceptance criteria for a novel AI device or a device requiring new clinical evidence of effectiveness.
- No AI component: The device described is a dental implant, a physical medical device, not an AI/ML-driven device. Thus, questions regarding AI-specific criteria (MRMC studies, standalone performance, ground truth establishment) are not applicable.
In summary, the provided text details a regulatory submission leveraging substantial equivalence, not a study demonstrating a device's performance against specific acceptance criteria.
To answer your prompt, I would need a document describing a new device that underwent a performance study to prove its efficacy or safety against pre-defined acceptance criteria, ideally including an AI/ML component if you intend to ask about those specific details.
§ 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.