(417 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) 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) are indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
The EK 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 EK Dental Abutments, 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 which is SA + Dglucose + NaCI.
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized.
The EK Dental Implants and Abutments are available in various lengths and diameters; configurations are listed in the table below.
The provided document is a 510(k) premarket notification for dental implants and abutments. It focuses on demonstrating substantial equivalence to previously cleared devices, rather than proving the device meets specific acceptance criteria through a clinical or performance study with a test set, ground truth, or expert readers as typically seen for novel AI/ML medical devices.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not directly applicable to this type of submission.
Instead, the document demonstrates substantial equivalence by comparing the proposed EK Dental Implants and Abutments to predicate and reference devices across several key characteristics:
- Intended Use: The proposed devices have the same intended use as the predicate devices (supporting single or multiple-unit restorations in edentulous mandibles and maxillae, for delayed loading).
- Design/Structure: The proposed implants have an internal hex connection, are submerged fixtures, and have a tapered body shape, similar to the predicate devices. The abutments are also comparable in design to their reference devices.
- Material: The implants use Pure Titanium Grade 4 (ASTM F67) and Titanium alloy Ti-6Al-4V (ASTM F136), which are standard materials also used in the predicate devices. Abutments use similar materials (Ti-6Al-4V, Co-Cr-Mo Alloy, Gold alloy as per the reference devices).
- Surface Treatment: The implants employ SA (Sandblasted and Acid etched) and NH (SA + D-glucose + NaCl) surfaces, which are consistent with the predicate and reference devices.
- Sterilization: Implants are gamma irradiated, and abutments are provided non-sterile for steam sterilization by the user, matching the predicate/reference devices.
- Packaging: Similar packaging methods are used as the predicate devices.
- Performance Characteristics (Non-Clinical):
- Biocompatibility: Not re-tested, as the materials and manufacturing processes are the same as predicate/reference devices.
- Sterilization Validation: Not re-tested for implants (same process as predicate) or for abutments (provided non-sterile like reference devices, with user steam sterilization).
- Shelf Life: Not re-validated for implants (same as predicate's 8-year validated shelf life and packaging) or for abutments (non-sterile, non-mechanical, no stated shelf life, similar to reference devices).
- Surface Treatment Characterization: Not re-tested, as surfaces are manufactured using the same process and materials as predicate/reference devices.
- Fatigue Testing: Conducted in accordance with ISO 14801. The worst-case implant and abutment configurations withstood 5,000,000 cycles without failure at a substantially equivalent load to the primary predicate.
- Clinical Performance Testing: No clinical performance report(s) were submitted, indicating that substantial equivalence was demonstrated through non-clinical data and comparison to predicates.
In a 510(k) substantial equivalence submission for a traditional medical device like a dental implant, the "acceptance criteria" are effectively the demonstration of sufficient similarity in technological characteristics and performance (often non-clinical) to a legally marketed predicate device. The "study" proving this device meets the "acceptance criteria" is the comprehensive comparison outlined above, coupled with relevant non-clinical testing (like fatigue testing).
Therefore, I cannot populate the table or answer the specific questions in the format requested, as they pertain to a different type of validation study (e.g., for an AI/ML diagnostic algorithm, which would involve a test set, ground truth established by experts, and statistical performance metrics).
§ 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.